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https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents
...documents developed by CDRH and other FDA Centers....the FD&C Act, and 21 CFR 807.100) from FDA prior to marketing the device. For ...
https://www.fda.gov/medical-devices/in-vitro-diagnostics/nucleic-acid-based-tests
List of nucleic acid-based tests that analyze variations in the sequence, structure...Nucleic Acid Based Tests Share Post Linkedin Email Print This is ...
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/monkeypox-mpox-and-medical-devices
Information on monkeypox (mpox) tests to address the public health emergency...(mpox) Test Developers FDA Cleared and EUA-Authorized Monkeypox (mpox) ...
https://www.fda.gov/media/134493/download
...24 New and Expanded Uses of Already FDA-Approved Drugs .......................instance, new approvals for uses of already FDA-approved drugs. Please ...
https://www.fda.gov/media/163320/download
Use for OSOM COVID-19 Antigen Home Test...OSOM COVID-19 Antigen Home Test – Instructions for Use - 1 - For use with anterior...USE The OSOM® COVID-19 ...
https://www.fda.gov/media/177451/download
Yatsushiro Plant, Japan (FEI:3002807562) on FDA inspection (240126) 2024-2171 Spotlight...inspection (Form FDA 482), inspectional observances (Form FD ...
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-granted-traditional-marketing-authorization-fda
COVID-19 tests that are authorized for marketing under FDA traditional premarket...COVID-19 Tests Granted Traditional Marketing Authorization by the F ...
https://www.fda.gov/media/138815/download
DTPM COVID-19 RT-PCR Test - Letter of Authorization...DTPM COVID-19 RT-PCR Test - Letter of Authorization /~11,i, { ~ tffll U.S. FOOD...AL 35968 ...
https://www.fda.gov/media/150274/download
...cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System - Letter...Device: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat ...
https://www.fda.gov/media/88518/download
Novel Coronavirus 2012 Real-time RT- PCR Assay - Letter of Authorization...Novel Coronavirus 2012 Real-time RT- PCR Assay - Letter of Authorization ...
https://www.fda.gov/media/141049/download
Biomeme SARS-CoV-2 Real-Time RT-PCR Test – Letter of Authorization...Biomeme SARS-CoV-2 Real-Time RT-PCR Test – Letter of Authorization March ...
https://www.fda.gov/media/141051/download
Authorization: Biomeme SARS-CoV-2 Real-Time RT-PCR Test – Patient Fact Sheet...Biomeme SARS-CoV-2 Real-Time RT-PCR Test – Patient Fact Sheet • Where ...
https://www.fda.gov/media/179281/download
SARS-CoV-2, Influenza A/B RSV nucleic acid test - Letter of Authorization June 07, 2024...SARS-CoV-2, Influenza A/B & RSV nucleic acid test EUA ...
https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety
The FDA recommends repeat testing following a negative result to reduce the...Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results ...
https://www.fda.gov/media/177285/download
Labcorp Monkeypox PCR Test Home Collection Kit - Letter of Authorization July...Ohio 43074 Device: Labcorp Monkeypox PCR Test Home Collection Kit EUA ...
https://www.fda.gov/medical-devices/in-vitro-diagnostics/influenza-diagnostic-tests
Influenza Diagnostic Tests Share Post Linkedin Email Print July 22, 2024 Laboratory...Laboratory developed tests (LDTs) for Highly Pathogenic Avian ...
https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-next-generation-sequencing-based-test-detect-very-low-levels-remaining-cancer
FDA authorizes first next generation sequencing-based test to detect very low...FDA News Release FDA authorizes first next generation sequencing-based ...
https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2...Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 Share Post ...
https://www.fda.gov/media/172669/download
...11/01/2022 Request to acquire the FDA 483 for FDA inspection of S6643 CHEMISCHE...official policy documents) between the FDA and NOAA SIP Program ...
https://www.fda.gov/media/152660/download
Davies 10/30/2020 Please provide all FDA 483 letters sent to businesses already...maintained, reviewed, or collected by FDA relating to correspondence ...
