| Fabricante | Prueba | Estado |
|---|---|---|
| Abbexa Ltd | abx294171 - COVID-19 IgG/IgM Rapid Test Kit | Eliminado - No debe distribuirse |
| Absology Co., Ltd. | Absoludy COVID-19 IgM/IgG Combo | Eliminado - No debe distribuirse |
| Absology Co., Ltd. | Absoludy COVID-19 IgM/IgG RAPID | Eliminado - No debe distribuirse |
| Absology Co., Ltd. | INIST COVID-19 IgM/IgG RAPID | Eliminado - No debe distribuirse |
| Accel Diagnostics, LLC | Rapid C2T Total Ab (IgG/IgM) Card | Eliminado - No debe distribuirse |
| Access Bio, Inc. | CareStart COVID-19 IgM/IgG | Autorización FDA |
| ACCOBiotech SDN.BHD | ACCO COVID-19 IgM/IgG TEST | Eliminado - No debe distribuirse |
| ADVAITE, Inc. | RapCov™ COVID-19 Rapid Test | No autorizado por la FDA |
| AI DE Diagnostic Co., Ltd. | SARS-CoV-2 IgG/IgM Antibody Test | No autorizado por la FDA |
| Alfa Scientific Designs, Inc. | Clarity COVID-19 IgG/IgM Antibody Test | Eliminado - No debe distribuirse |
| Alfa Scientific Designs, Inc. | Instant-view plus COVID-19 IgG/IgM Antibody Test | Eliminado - No debe distribuirse |
| AngelWorld Biotech Manufacturing FZ LLC | AngelWorld V2.0 COVID-19 IgG/IgM Antibody Rapid Test | Eliminado - No debe distribuirse |
| Anhui Deepblue Medical Technology Co., Ltd. | COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Antagen Pharmaceuticals, Inc. | COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) | No autorizado por la FDA |
| Antibody BioPharm, Inc. | COVID-19 IgM/IgG POCT Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Arbor Assays | DetectX SARS-CoV-2 IgG ELISA Kit | Eliminado - No debe distribuirse |
| Arbor Vita Corporation | CoVisa IgG Test | Eliminado - No debe distribuirse |
| Artron BioResearch Inc./ Artron Laboratories Inc. | COVID-19 IgM/IgG Antibody Test | Eliminado - No debe distribuirse |
| Asan Pharmaceutical Co., Ltd. | Asan Easy Test COVID-19 IgG/IgM | Eliminado - No debe distribuirse |
| Assure Tech. (Hangzhou Co., Ltd) | Assure COVID-19 IgG/IgM Rapid Test Device | Autorización FDA |
| Atlas Link (Beijing)Technology Co., Ltd | NovaTest: One Step COVID-19 IgG/IgM rapid test | Eliminado - No debe distribuirse |
| Audacia Bioscience | CMC-19D SARS-CoV2 (COVID-19) Rapid Antibody Test | Eliminado - No debe distribuirse |
| Aurora Biomed Inc. | COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold) | Eliminado - No debe distribuirse |
| Autobio Diagnostics Co. Ltd. | Anti-SARS-CoV-2 Rapid Test | Eliminado - No debe distribuirse |
| Axium BioResearch, Inc. | AxiumHealth COVID-19 IgG/IgM Antibody Test | Eliminado - No debe distribuirse |
| Beijing Decombio Biotechnology Co., Ltd. | Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood) | Eliminado - No debe distribuirse |
| Beijing DiaGreat Biotechnologies Co. Ltd. | 2019-nCoV IgM Antibody Determination Kit | Eliminado - No debe distribuirse |
| Beijing DiaGreat Biotechnologies Co. Ltd. | 2019-nCoV IgG/IgM Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Beijing DiaGreat Biotechnologies Co. Ltd. | 2019-nCoV IgG Antibody Determination Kit | Eliminado - No debe distribuirse |
| Beijing Kewei Clinical Diagnostic Reagent Inc. | Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab Rapid Test | Autorización FDA |
| Beroni Group | SARS-CoV-2 IgG/IgM Antibody Detection Kit | Eliminado - No debe distribuirse |
| BestNovo (Jiangsu) Medical Technology Co., Ltd. | BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Biobase Biodustry (Shandong) Co., Ltd. | SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Biocan Diagnostics Inc. | Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Strip Format) | No autorizado por la FDA |
| Biocan Diagnostics Inc. | Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (cassette format) | Autorización FDA |
| Biohit Healthcare (Hefei) Co. Ltd. | Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit | Autorización FDA |
| Biolidics Limited | 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| BioMedomics, Inc. | COVID-19 IgM-IgG rapid test | Eliminado - No debe distribuirse |
| Biomerica, Inc. | COVID-19 IgG/IgM Rapid Test | Eliminado - No debe distribuirse |
| Bioscience(Chongqing) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Eliminado - No debe distribuirse |
| Bioscience(Chongqing) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Eliminado - No debe distribuirse |
| Bioscience(Tianjin) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody | Eliminado - No debe distribuirse |
| Bioscience(Tianjin) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody | Eliminado - No debe distribuirse |
| Bioscience(Tianjin) Diagnostic Technology Co., Ltd. | Novel Coronavirus (2019-nCoV) Antibody Rapid Test | Eliminado - No debe distribuirse |
| BioSure (UK) Limited | BioSURE COVID-19 Antibody Rapid Test (REF: 92001COV) | No autorizado por la FDA |
| Biosynex SA | COVID-19 BSS | No autorizado por la FDA |
| BioSys Laboratories, Inc. | BioSys Plus COVID-19 IgM/IgG Rapid Test | Eliminado - No debe distribuirse |
| Bloom Diagnostics AG | Bloom COVID-19 Test | No autorizado por la FDA |
| Boditech Med Inc | Biosynex AFIAS COVID-19 Ab serological tests | No autorizado por la FDA |
| Boston Bio Lab Inc. | Boston Bio EZ Covid-19 | No autorizado por la FDA |
| Boston Biopharma Inc. | BB Rapid-MT | Eliminado - No debe distribuirse |
| BreviTest Technologies, LLC | Brevitest SARS-CoV-2 IgG Test | Eliminado - No debe distribuirse |
| BTNX, Inc. | Rapid Response™ COVID-19 IgG/IgM Test Cassette | Eliminado - No debe distribuirse |
| Calbiotech, Inc. | ErbaLisa® COVID-19 IgG | Eliminado - No debe distribuirse |
| Camtech Diagnostics Pte Ltd | Camtech Covid-19 IgM/IgG 2C Rapid Test | Eliminado - No debe distribuirse |
| Camtech Diagnostics Pte Ltd | Camtech Covid-19 IgM/IgG 1C Rapid Test | Eliminado - No debe distribuirse |
| CareHealth America Corporation | CoviCheck™ COVID-19 IgM/IgG Antibody Test | No autorizado por la FDA |
| Cell ID Pte Ltd | Smart COVID-19 IgM/IgG Rapid Diagnostic Test (RDT) | Eliminado - No debe distribuirse |
| Cellex Inc. | qSARS-CoV-2 IgG/IgM Rapid Test | Autorización FDA |
| Changchun Wancheng Bio-Electron Co., Ltd. | COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) | Eliminado - No debe distribuirse |
| Chembio Diagnostic Systems, Inc. | DPP COVID-19 IgM/IgG System | Eliminado - No debe distribuirse |
| Chemtron Biotech, Inc. | Chemtrue®Rapid COVID-19 IgM/IgG Antibody Test | Eliminado - No debe distribuirse |
| ClearSign Diagnostics Co | Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test | Eliminado - No debe distribuirse |
| ClearSign Diagnostics Co., LLC | ClearSign Diagnostics SARS-CoV-2 Antibody (IgM and IgG) Test | No autorizado por la FDA |
| Core Technology Co., Ltd. | CoreTest COVID-19 IgM/IgG Ab Test | No autorizado por la FDA |
| Core Technology Co., Ltd. | RapidTest COVID-19 IgM/IgG Ab Test | No autorizado por la FDA |
| CoreMedica Laboratories, Inc. | Capillary Blood Collection Kit & Laboratory Analysis for SARS-CoV-2 ELISA IgG and IgM | Eliminado - No debe distribuirse |
| CTK Biotech, Inc. | OnSite® COVID-19 IgG/IgM Rapid Test | Eliminado - No debe distribuirse |
| Diabetomics, Inc | CovAbScreen™ SARS-CoV-2 Ab Test | No autorizado por la FDA |
| Diazyme Laboratories, Inc. | Diazyme SARS-CoV-2 Antibody Rapid Test | Eliminado - No debe distribuirse |
| Discount Diagnostics | Global WholeHealth Partners RDT IgG/IgM Antibody test | Eliminado - No debe distribuirse |
| Dynamiker Biotechnology (Tianjin) Co., Ltd. | RapidCOV™ 2019-nCOV IgG/IgM Rapid Test | No autorizado por la FDA |
| EACHY Biopharmaceuticals Co., Ltd. | AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) | Eliminado - No debe distribuirse |
| EACHY Biopharmaceuticals Co., Ltd. | AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | Eliminado - No debe distribuirse |
| EACHY Biopharmaceuticals Co., Ltd. | SmartScreen COVID-19 IgM/IgG Test Kit | Eliminado - No debe distribuirse |
| Edinburgh Genetics Limited | ActivXpress+ COVID-19 IgG/IgM Immunoassay Complete Testing Kit | Eliminado - No debe distribuirse |
| Enable Biosciences Inc. | ADAP SARS-CoV-2 Total Antibody Assay | No autorizado por la FDA |
| EpiGentek | SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit | Eliminado - No debe distribuirse |
| ET Healthcare Inc. | Pylon COVID-19 IgM/IgG Assay | No autorizado por la FDA |
| Excelsior Bio-System, Inc. | EBSALERT SARS-CoV-2 Antibody Rapid test | No autorizado por la FDA |
| Fosun Pharma USA Inc. | Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Eliminado - No debe distribuirse |
| Freedom For All Diagnostics™, Inc | SARS-CoV-2 IgM/IgG Antibody Assay Kit | No autorizado por la FDA |
| GenBody Inc. | GenBody COVID-19 IgM/IgG | Eliminado - No debe distribuirse |
| Genelogic Research Limited | Genelogic COVID-19 IgM/IgG Antibody Rapid Test | No autorizado por la FDA |
| GeneScan Diagnostics, LLC | AmeriDx® SARS-CoV-2 IgG/IgM Rapid Test Kit | Eliminado - No debe distribuirse |
| GeneScan Diagnostics, LLC | AmeriDx® SARS-CoV-2 IgG/IgM-T Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Genesprint Group, Ltd. | Genesprint Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 test | Eliminado - No debe distribuirse |
| Genlantis Diagnostics, Inc. | CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test | Eliminado - No debe distribuirse |
| Genobio Pharmaceutical Co., Ltd. | COVID-19 IgM/IgG Lateral Flow Assay | Eliminado - No debe distribuirse |
| Genrui Biotech Inc. | Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) | No autorizado por la FDA |
| Getein Biotech Inc. | One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold) | Eliminado - No debe distribuirse |
| Gold Standard Diagnostics | INgezim® COVID 19 CROM Rapid Test Kit | No autorizado por la FDA |
| Goldsite Diagnostics Inc | SARS-CoV-2 IgG/IgM ki | No autorizado por la FDA |
| GREEN ENERGY TECHNOLOGY SOLUTIONS, LLC | AMP Rapid Test SARS-CoV-2 IgG/IgM | Eliminado - No debe distribuirse |
| Guangdong Hecin Scientific, Inc. | SARS-CoV-2 IgM Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Guangzhou Decheng biotechnology | DOCHEK™ SARS-CoV-2 Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Guangzhou Fenghua Bioengineering Co., Ltd. | SARS-CoV-2 IgG/IgM Rapid Test | Eliminado - No debe distribuirse |
| Guangzhou Wondfo Biotech Co., Ltd. | SARS-CoV-2 Antibody Test | No autorizado por la FDA |
| H-Guard (China) Co., Ltd. | Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Eliminado - No debe distribuirse |
| H&Z Life Science Co. Ltd. | Anti-COVID-19 Virus IgM/IgG Test Kit (lateral flow assay) | No autorizado por la FDA |
| Hangzhou AllTest Biotech Co., Ltd. | AllTest 2019-nCoV IgG/IgM Rapid Test Cassette | Eliminado - No debe distribuirse |
| Hangzhou AllTest Biotech Co., Ltd. | AllTest COVID-19 IgG/IgM Rapid Test Strip | Eliminado - No debe distribuirse |
| Hangzhou Biotest Biotech Co., Ltd. | RightSign COVID-19 IgG/IgM Rapid Test Cassette | Autorización FDA |
| Hangzhou Clongene Biotech Co., Ltd. | Clungene COVID-19 IgM/IgG Rapid Test Cassette | No autorizado por la FDA |
| Hangzhou Clongene Biotech Co., Ltd. | COMBRA COVID-19 IgM/IgG Rapid Test Cassette | Eliminado - No debe distribuirse |
| Hangzhou Laihe Biotech Co., Ltd. | LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Autorización FDA |
| Hangzhou Realy Tech Co Ltd. | 2019-nCOV IgG/IgM Rapid Test | Eliminado - No debe distribuirse |
| Hangzhou Sejoy Electronics & Instrument Co., Ltd. | COVID-19 IgG/IgM Rapid Test Cassette | No autorizado por la FDA |
| Hangzhou Testsea Biotechnology Co., Ltd. | One Step SARS-CoV2(COVID-19) IgG/IgM Test | Eliminado - No debe distribuirse |
| Healgen Scientific LLC | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Autorización FDA |
| Horizon Pharmaceuticals, Inc. | Horizon RDT SARS CoV-2 IgM/IgG Antibody Test | No autorizado por la FDA |
| HUMASIS Co., Ltd. | Humasis COVID-19 IgG/IgM Test | No autorizado por la FDA |
| Hunan RunKun Pharmaceutical Co., Ltd. | SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| ICT international | 2019-nCoV IgG/IgM Rapid Test Cassette | Eliminado - No debe distribuirse |
| IMMY, Inc. | clarus SARS-CoV-2 Total Antibody EIA | Eliminado - No debe distribuirse |
| Innovation Biotech (Beijing) Co., Ltd. | SARS-COV-2 IgM/IgG Antibody Rapid Test (Immunochromatographic Method) | Eliminado - No debe distribuirse |
| INNOVITA (Tangshan) Biological Technology Co., Ltd. | 2019-nCoV Ab Test (Colloidal Gold) | No autorizado por la FDA |
| Invenio Medical | COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) | Eliminado - No debe distribuirse |
| Invenio Medical | COVID-19 IgG/IgM Ab Rapid Test | Eliminado - No debe distribuirse |
| Jiangsu Dablood Pharmaceutical Co, Ltd. | AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test | No autorizado por la FDA |
| Jiangsu Dablood Pharmaceutical Co, Ltd. | AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test | Eliminado - No debe distribuirse |
| Jiangsu Dablood Pharmaceutical Co. Ltd. | COVID-19 IgM/IgG Rapid Test | Eliminado - No debe distribuirse |
| Jiangsu Eubo Biotechnology Co., Ltd. | EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) | Eliminado - No debe distribuirse |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold) | No autorizado por la FDA |
| Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. | SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. | ThermoGenesis SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Jiangsu Well Biotech Co., Ltd. | Orawell IgM/IgG Rapid Test | Autorización FDA |
| JOYSBIO (Tianjin) Biotechnology Co., Ltd. | COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Lepu Medical Technology (Beijing) Co., Ltd. | Lepu SARS-CoV-2 Antibody Rapid Test | Eliminado - No debe distribuirse |
| Leritas LLC | DualTec SARS-CoV-2 Test Kit | Eliminado - No debe distribuirse |
| Lifeassay | Test-it COVID-19 IgM/IgG Lateral Flow Assay | Eliminado - No debe distribuirse |
| Liming BioProducts Co. Ltd. | SARS-CoV-2 lgM/lgG Antibody Rapid Test | No autorizado por la FDA |
| LumiQuick Diagnostics, Inc. | QuickProfile™ 2019-nCoV IgG/IgM Antibody Test | Eliminado - No debe distribuirse |
| Maccura Biotechnology Co., Ltd. | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method | No autorizado por la FDA |
| MBio Diagnostics, Inc. | LightDeck® COVID-19 Total Antibody Test | No autorizado por la FDA |
| MedicalSystem Biotechnology Co., Ltd. | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Eliminado - No debe distribuirse |
| Medicon Company Limited | Trueline COVID-19 IgG/IgM Rapid Test | No autorizado por la FDA |
| MedMira Inc. | REVEALCOVID-19™ Total Antibody Test | No autorizado por la FDA |
| Megna Health Inc. | Rapid COVID-19 IgM/IgG Combo Test Kit | Autorización FDA |
| Melbourne Biotech | MB COVID-19 Antibody Detection Kit | Eliminado - No debe distribuirse |
| Micropoint Biosciences, Inc. | mLabs® SARS-CoV-2 IgG and IgM Assay | No autorizado por la FDA |
| Mokobio Biotechnology R&D Center | SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay | Eliminado - No debe distribuirse |
| Mokobio Biotechnology R&D Center Inc | COVID-19 IgM & IgG Rapid Test (Colloidal Gold Assay) | No autorizado por la FDA |
| Monarch Global Health LLC | Magellan IgM and IgG Antibody Rapid Test Kit for Serum | No autorizado por la FDA |
| Multi-G bvba | COVID-19 IgG/IgM Rapid Test Cassette | No autorizado por la FDA |
| Nanjing Liming Bio-products Co.,Ltd | SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit | No autorizado por la FDA |
| Nanjing Norman Biological Technology Co., Ltd | Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) | No autorizado por la FDA |
| Nanjing SYNTHGENE Medical Technology Co., Ltd. | SYNTHGENE COVID-19 IgM/IgG Rapid Detection Kit (Colloidal Gold Method) | No autorizado por la FDA |
| Nanjing Vazyme Medical Technology Co., LTD. | 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | Eliminado - No debe distribuirse |
| Nanjing Weiyun Biotechnology Co., Ltd. | SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Nano-Ditech Corporation | Nano-Check COVID-19 IgG/IgM Antibody Test | Eliminado - No debe distribuirse |
| NanoEntek, Inc. | FREND COVID-19 IgG/IgM Duo | Eliminado - No debe distribuirse |
| Nanomix, Inc. | Nanomix eLab® COVID-19 Rapid IgG/IgM Panel | No autorizado por la FDA |
| NanoResearch, Inc. | NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test | No autorizado por la FDA |
| Nantong Diagnos Biotechnology Co., Ltd. | (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) | Eliminado - No debe distribuirse |
| Nantong Egens Biotechnology Co., Ltd | EGENS COVID-19 IgG/IgM Rapid Test Kit | Eliminado - No debe distribuirse |
| Naturitious LLC | Viralert COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT | Eliminado - No debe distribuirse |
| Newscen Bio-Pharmaceutical Co., Ltd. | COVID-19 Microfluidic IgG/IgM Test | No autorizado por la FDA |
| NewScen Coast Bio-Pharmaceutical Co., Ltd. | Covid-19 IgG/IgM Rapid Test | No autorizado por la FDA |
| Nirmidas Biotech, Inc. | MidaSpot™ COVID-19 Antibody Combo Detection Kit | No autorizado por la FDA |
| Nirmidas Biotech, Inc. | Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Autorización FDA |
| Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) | Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) | No autorizado por la FDA |
| NOW Diagnostics, Inc. | ADEXUSDx® COVID-19 Test | No autorizado por la FDA |
| Oncosem Onkolojik Sistemler San.ve Tic. A.S | CRT (COVID-19 Rapid Test) | Eliminado - No debe distribuirse |
| One Milo, Inc. | InstantRapid® SARS CoV-2 IgG IgM Test | Eliminado - No debe distribuirse |
| Pacific Connect Group LLC (US) | SARS-CoV-2 IgG/IgM Rapid Test Kit | Eliminado - No debe distribuirse |
| PCL Inc. | COVID19 IgG/IgM Rapid Gold | Eliminado - No debe distribuirse |
| PerGrande BioTech Development Co., Ltd. | SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) | Eliminado - No debe distribuirse |
| Phamatech | COVID19 IgG / IgM Rapid Test | Eliminado - No debe distribuirse |
| Pharmact GmbH, | BelTEST It SARS CoV-2 IgM/IgG Rapid Test (Pharmact CoV-2 Rapid Test) | No autorizado por la FDA |
| Pinnacle Biolabs | SARS-CoV-2 IgG/IgM Rapid Test | Eliminado - No debe distribuirse |
| Profarma, UAB | ProRapid Coronavirus Disease (SARS-CoV-2) IgG/IgM Rapid Test Cassette Single Use Kit | Eliminado - No debe distribuirse |
| Promedical | COVID-19 Rapid Test | Eliminado - No debe distribuirse |
| Promedical Equipment Pty Ltd | Promedical IgM/IgG Rapid Detection Kit | No autorizado por la FDA |
| Prometheus Bio Inc. | 2019-nCoV IgG/IgM Test (Whole blood/Serum/Plasma) Colloidal Gold | Eliminado - No debe distribuirse |
| ProteomeTech Inc. | KOVIcheck COVID-19 IgG/IgM | Eliminado - No debe distribuirse |
| Pure Genetic Medical Ltd. (Distributed Boson Biotech Ltd. Co) | Rapid 2019-nCoV IgG/IgM Combo Test Card | Eliminado - No debe distribuirse |
| Qingdao Hightop Biotech Co., Ltd. | HIGHTOP 2019-nCoV IgM/IgG Rapid Test | No autorizado por la FDA |
| RayBiotech Life, Inc. | Novel Coronavirus (SARS-CoV-2) IgM and IgG Antibody Detection Kits for Serum | Eliminado - No debe distribuirse |
| RayBiotech Life, Inc. | Novel Coronavirus (SARS-CoV-2) IgM and IgG Dual Combined Antibody Detection Kit for Serum | Eliminado - No debe distribuirse |
| Reszon Diagnostics International Sdn. Bhd. | RESZON (COVID-19) (Sars-Cov-2) IgG/IgM Antibody Test | Eliminado - No debe distribuirse |
| Reszon Diagnostics International Sdn. Bhd. | Reszon COVID-19 Rapid IgG/IgM Test | Eliminado - No debe distribuirse |
| Ring Biotechnology Co Ltd | COVID-19 IgM/IgG Rapid Test Kit | No autorizado por la FDA |
| SA Scientific | SAS™ COVID-19 Antibody Detection test | No autorizado por la FDA |
| SA Scientific Ltd. | SAS™ COVID-19 Total Antibody Detection Test | No autorizado por la FDA |
| Safecare Biotech (Hagzhou) Co., Ltd. | SAFECARE COVID-19 IgG/IgM Rapid Test Device | Eliminado - No debe distribuirse |
| Saladax Biomedical | COVID-19 IgG/IgM Rapid Antibody Test | Eliminado - No debe distribuirse |
| Salofa Oy | Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette | Autorización FDA |
| Salofa Oy Clarity | COVIBLOCK™ COVID-19 IgG/IgM Antibody Test | No autorizado por la FDA |
| ScheBo® • Biotech AG ScheBo® | SARS-CoV-2 Quick | Eliminado - No debe distribuirse |
| Sciteck Diagnostics | COVID19 Automated Antibody Assay | No autorizado por la FDA |
| SD Biosensor | STANDARD Q COVID-19 IgM/IgG Duo | Eliminado - No debe distribuirse |
| Sensing Self Pte. Ltd. | COVID-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Kit | Eliminado - No debe distribuirse |
| Shandong ThinkLab Biotechnology Co., Ltd.: | 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay) | No autorizado por la FDA |
| Shanghai Eugene Biotech Co., Ltd. | SARS-CoV2 (COVID-19) IgG/IgM Rapid Test | Eliminado - No debe distribuirse |
| Shanghai Fosun Long March Medical Science Co., Ltd. | Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Eliminado - No debe distribuirse |
| Shanghai Liangrun Biomedicine Technology Co., Ltd. | Liangrun COVID-19 IgM/IgG Antibody Test | No autorizado por la FDA |
| Shanghai Outdo Biotech Co., Ltd. | Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test | Eliminado - No debe distribuirse |
| Shenzen Landwind Medical Co., Ltd. | COVID-19 IgG/IgM Rapid Test | Eliminado - No debe distribuirse |
| Shenzhen Kingfocus Biomedical Engineering Co., Ltd. Immunochromatography) | True-Dot™ Novel Coronavirus (2019-nCoV) IgM/IgG Rapid Antibody Detection Kit (Quantum Dot | No autorizado por la FDA |
| Shenzhen Lvshiyuan Biotechnology Co., Ltd | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Eliminado - No debe distribuirse |
| Shenzhen Watmind Medical Co. | SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit | No autorizado por la FDA |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Shin Jin Medics Inc. | DIAKEY COVID-19 IgM/IgG Rapid Test | No autorizado por la FDA |
| Singuway Biotech Inc. | COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | No autorizado por la FDA |
| Sinocare, Inc. | SARS-CoV-2 Antibody Test Kit (Colloidal Gold Method) | Eliminado - No debe distribuirse |
| Sober Holdings, LLC | COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) | Eliminado - No debe distribuirse |
| Sober Holdings, LLC | ProMed Rapid Test | Eliminado - No debe distribuirse |
| Spartacus-Biomed | LFA COVID-19 IgG & IgM Rapid Test Device | No autorizado por la FDA |
| Spring Health Care AG | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | No autorizado por la FDA |
| Sugentech, Inc. | SGTi-flex COVID-19 IgG | Autorización FDA |
| Sugentech, Inc. | SGTi-flex COVID-19 IgM/IgG | Eliminado - No debe distribuirse |
| Sunbeam Laboratories, LLC. | Sunbeam Laboratories Covid-19 Rapid Test Kit | Eliminado - No debe distribuirse |
| Sure Bio-tech | API Covid-Rapid IgM/IgG Antibody Test Kit | Eliminado - No debe distribuirse |
| Sure Bio-Tech | API Pharma Covid-Rapid IgM/IgG Antibody Test | Eliminado - No debe distribuirse |
| SUREDX | V-CHEK™ SARS-CoV-2 Antibody Rapid Test Kit | No autorizado por la FDA |
| Suzhou Kangheshun Medical Technology Co., Ltd | SARS-CoV-2 IgG/IgM Rapid Test Cassette | Eliminado - No debe distribuirse |
| TBG Biotechnology Corp. | TBG SARS-CoV-2 IgG / IgM Rapid Test Kit | Autorización FDA |
| Telepoint Medical Services | SARS-CoV-2 IgG/IgM Rapid Qualitative Test | Eliminado - No debe distribuirse |
| TheraTest Laboratories, Inc. | EL-Anti-SARS-CoV-2 IgG | Eliminado - No debe distribuirse |
| Tianjin Beroni Biotechnology Co. Ltd | SARS-CoV-2 IgG/IgM Antibody Detection Kit | Eliminado - No debe distribuirse |
| Tianjin New Bay Bioresearch Co., Ltd. | Quikpac II COVID-19 IgG/IgM | Eliminado - No debe distribuirse |
| TM Testing, Inc. | TM Test Kits, CoVID-19 Rapid Antibody Serology Test | Eliminado - No debe distribuirse |
| Top Biotech Sdn. Bhd | TOP RAPID COVID-19 Rapid Antibody IgG/IgM Test Kit | No autorizado por la FDA |
| Truvian Sciences Inc. | Easy Check COVID-19 IgM/IgG™ POC Antibody Test | No autorizado por la FDA |
| Türklab Tibbi Malzemeler San. ve Tic. A.Ş. | INFO SARS-CoV-2 IgM/IgG Ab Test | No autorizado por la FDA |
| Türklab Tibbi Malzemeler San. ve Tic. A.Ş. | TOYO SARS-CoV-2 IgM/IgG Ab Test | No autorizado por la FDA |
| UC Berkeley Innovative Genomic Institute | UC Berkeley Innovative Genomic Institute | No autorizado por la FDA |
| Universal Meditech Inc. | DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test | Eliminado - No debe distribuirse |
| VicTorch Meditek Inc. | COVID-19 IgG/IgM Rapid test Cassette | No autorizado por la FDA |
| Victory Square Health, Inc. | Safetest Covid-19 IgG/IgM Rapid Test | No autorizado por la FDA |
| VirIntel, LLC | VirIntel COVID-19 Antibody Test | No autorizado por la FDA |
| VITA Testing | COVID-19 IgM/IgG Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Vitro Diagnostics | Vitro Diagnostics COVID 19 IgG/IgM Rapid Test Cassette Serology Device | Eliminado - No debe distribuirse |
| VivaChek Biotech (Hangzhou) Co., Ltd. | VivaDiag COVID-19 IgM/IgG Rapid Test | No autorizado por la FDA |
| Vivera Pharmaceuticals, Inc. | Vivera Pharma COVID-19 Rapid Test | Eliminado - No debe distribuirse |
| W.H.P.M., Inc. | COVID-19 IgM/IgG Rapid Test | Eliminado - No debe distribuirse |
| W.H.P.M., Inc. | COVISURE™ COVID-19 IgM/IgG Rapid Test | Eliminado - No debe distribuirse |
| Wuhan EasyDiagnosis | Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test | Eliminado - No debe distribuirse |
| Wuhan UNscience Biotechnology Co., Ltd. | Coronavirus-19 (COVID-19) Antibody (IgM/IgG) Rapid Test Kit (Colloidal gold immunochromatography) | No autorizado por la FDA |
| Wuhu 3H Biotechnology Co. Ltd. | COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) | Eliminado - No debe distribuirse |
| Xiamen AmonMed Biotechnology Co., Ltd. | COVID-19 IgM/IgG test kit (Colloidal Gold) | No autorizado por la FDA |
| Xiamen AmonMed Biotechnology Co., Ltd. | Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) | Eliminado - No debe distribuirse |
| Xiamen Biotime Biotechnology Co., Ltd. | BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test | Autorización FDA |
| Xiamen Wiz Biotech Co., Ltd. | Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 | Eliminado - No debe distribuirse |
| ZEUS Scientific, Inc. | ZEUS Rapid SARS-CoV-2 IgM/IgG Test System | Eliminado - No debe distribuirse |
| Zhejiang GENE SCIENCE Co., Ltd | Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography) | No autorizado por la FDA |
| Zhejiang Orient Gene Biotech, Co., Ltd. | COVID-19 IgG/IgM Rapid Test Cassette | No autorizado por la FDA |
| Zhengzhou Fortune Bioscience Co., Ltd. | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | Eliminado - No debe distribuirse |
| Zhengzhou Fortune Bioscience Co., Ltd. | COVID-19 IgM Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Zhengzhou Fortune Bioscience Co., Ltd. | COVID-19 IgG Antibody Rapid Test Kit | Eliminado - No debe distribuirse |
| Zhongshan Bio-Tech Co Ltd. | SARS-CoV-2 IgM/IgG (GICA) | Eliminado - No debe distribuirse |
| Zhuhai Encode Medical Engineering Co., Ltd | Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device | Eliminado - No debe distribuirse |
| Zhuhai Keyu Biological Engineering Co., Ltd. | SARS-CoV-2 IgG/IgM Rapid Test Kit | Eliminado - No debe distribuirse |
| Zhuhai Livzon Diagnostics, Inc. | Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) | Eliminado - No debe distribuirse |
| Zybio Inc. | SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method) | No autorizado por la FDA |
Fuentes:
Autorizaciones FDA
Pruebas Eliminadas
Pruebas No autorizadas