fda approved test kits list | 合法醫療器材資訊網
2021年6月16日—Anti-HIVSpecimenCollectionDevices,TestingServices,andHomeTestKitsAnti-HIV-2Assays-HumanImmunodeficiencyVirusType2,2020年12月30日—InfographicprovidesavisualizationofdataassociatedwithCDRH'sauthorizationofcoronavirus(COVID-19)DiagnosticTestsin2020.,2021年3月1日—CII-ArboViroPlexrRT-PCRAssay(ColumbiaUniversity)·TaqPathZikaVirusKit(ThermoFisherScientific)·Gene-RADARZikaVirusTest( ...,2021年5月25日—Forthispage,theFDAhassummarizedtheexpectedperformanceofthetestsithas...Test:BioCheck...
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Complete List of Donor Screening Assays for Infectious ... | 合法醫療器材資訊網
2021年6月16日 — Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits Anti-HIV-2 Assays - Human Immunodeficiency Virus Type 2 Read More
COVID | 合法醫療器材資訊網
2020年12月30日 — Infographic provides a visualization of data associated with CDRH's authorization of coronavirus (COVID-19) Diagnostic Tests in 2020. Read More
Emergency Use Authorizations for Medical Devices | 合法醫療器材資訊網
2021年3月1日 — CII-ArboViroPlex rRT-PCR Assay (Columbia University) · TaqPath Zika Virus Kit (Thermo Fisher Scientific) · Gene-RADAR Zika Virus Test ( ... Read More
EUA Authorized Serology Test Performance | 合法醫療器材資訊網
2021年5月25日 — For this page, the FDA has summarized the expected performance of the tests it has ... Test: BioCheck SARS-CoV-2 IgG Antibody Test Kit Read More
FDA has released a total of 178 COVID – 19 Test Kits (60 ... | 合法醫療器材資訊網
To date, FDA has released a total of 178 COVID – 19 Test Kits (60 – PCR based, 69 – Rapid Antibody, 45 – Immunoassay and 4 – Others) Click the […] Read More
In-Depth: 32 FDA-Approved COVID | 合法醫療器材資訊網
2020年4月23日 — In-Depth: 32 FDA-Approved COVID-19 Testing Kits · 1. InBios Smart Detect SARS-CoV-2 rRT-PCR Kit · 2. Gnomegen COVID-19 RT-Digital PCR ... Read More
List of Cleared or Approved Companion Diagnostic Devices ... | 合法醫療器材資訊網
2021年6月4日 — List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) · Gilotrif (afatinib) - NDA 201292 · Iressa (gefitinib) - NDA ... Read More
LIST OF FDA APPROVED COVID | 合法醫療器材資訊網
2020年3月19日 — PRESS STATEMENT March 19, 2020 The Food and Drug Administration (FDA) has released today a list of approved COVID-19 test kits for ... Read More
List of SARS | 合法醫療器材資訊網
2021年6月3日 — https://www.fda.gov/medical-devices/emergency-situations-medical-devices/ ... The COVID-19 diagnostic tests approved by the Ministry of Health, ... List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to. Read More
Removal Lists of Tests that Should No Longer Be Used andor ... | 合法醫療器材資訊網
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