Laboratory Developed Tests | 合法醫療器材資訊網

2021年6月23日 — List of ASCA-accredited testing laboratories and their respective ... to the currently FDA-recognized versions of the standards and test ... Read More

FDA does not endorse any private laboratory firms, nor requires specific methods to be used for PLAPs. Methods link herein are provided as a courtesy, but ... Read More

2017年12月28日 — You can find information about each home or lab test that FDA has approved or cleared by searching FDA's Database of In Vitro Diagnostic ... Read More

2018年9月27日 — A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. Read More

6 天前 — On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain ... Read More

2016年10月10日 — The FDA classifies laboratory tests based on the level of control needed to assure that the device is safe and effective. Laboratory tests that ... Read More

FDA Laboratory Testing Company. Polyhedron Laboratories performs U.S. Food and Drug Administration (FDA) testing to CFR standards. A list of these tests are ... Read More

Avomeen is a FDA-Registered Laboratory. Our scientists have years of experience in analytical testing services & both safety and regulatory consulting. Read More

Dear All, Anyone of you have the list of approved test lab by FDA? THanks, SP. Read More

2021年4月14日 — US FDA announces medical device testing laboratories accredited under ASCA program. Questions? Request more information from our specialists. Read More