Find All FDA | 合法醫療器材資訊網

2017年12月28日—YoucanfindinformationabouteachhomeorlabtestthatFDAhasapprovedorclearedbysearchingFDA'sDatabaseofInVitroDiagnostic ...

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 (IVD) Tests.

To use this database,

enter a search term (for example the type of test, name, company, or other key word) in the blank space click on “Search” review the listing of products that match your search term select any products for additional information (including Decision Summaries) Link to Database of In Vitro Diagnostic (IVD) Tests

Content current as of:

12/28/2017

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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

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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

Find All FDA | 合法醫療器材資訊網

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

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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

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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

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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

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

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

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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

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