FDA-manualer og brugervejledninger

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FDA-manualer

Seneste indlæg, udvalgte manualer og manualer relateret til forhandlere for dette mærke tag.

FDA COVI-Go SARS-CoV-2 Ag Selvtest instruktionsmanual

3. april 2023
FDA COVI-Go SARS-CoV-2 Ag Selvtest Produktinformation Beregnet til brug med forreste nasale podningsprøver. Kun til nødbrugstilladelse (EUA). Kun til in vitro-diagnostisk brug. Sættets indhold inkluderer en aftagelig pose, testenhed, næsepodning og en foliepose med hak. Personer…

FDA DAYVIGO Tablet Instruktionsmanual

13. januar 2023
FDA DAYVIGO Tablet HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DAYVIGO® safely and effectively. See full prescribing information for DAYVIGO®. DAYVIGO® (lemborexant) tablets, for oral use, CIV Initial U.S. Approval: 2019 INDICATIONS…

FDA Assure-100 Rapid COVID-19 Home Test Instruktionsmanual

3. januar 2023
Rapid COVID-19 Home Test Assure-100 Rapid COVID-19 Home Test For use under Emergency Use Authorization (EUA) only.Carefully read instructions before performing test.Failure to follow the instructions may result in inaccurate test results.An anterior nasal swab can be self-collected by an…

FDA CVM eSubmitter Data Book User Guide

29. november 2022
FDA CVM eSubmitter Data Book User Guide Introduction The value of the Data Book is to provide a means of storing information from within a section of a submission to be reused at a later time. Depending on the section,…

FDA CVM eSubmitter Master File Brugervejledning

25. november 2022
FDA CVM eSubmitter Master File Introduktion Mesteren File Bog giver et middel til at opbevare Master File information to be reused across submissions and associated books. Reusing this data makes building a submission more efficient, as well as ensuring data…

FDA COVID-19 Nano Test Instruktionsmanual

24. november 2022
FDA COVID-19 Nano Test Instruction Manual The Nano Test for COVID-19 will be performed at Nanobiosym Precision Testing Services, located at 245 First Street, Suite 175, Cambridge, MA 02142, that is certified under the Clinical Laboratory Improvement Amendments of 1988…

FDA Food Facility Registration User Guide

29. august 2022
FDA Food Facility Registration IMPORTANT INSTRUCTION Step 1 – Select the registration you want to update Once you are logged in to FDA Industry Systems/your Online Account Administration (OAA) account, choose the "Food Facility Registration" (FFR) system. Next, choose the…