Priročniki in uporabniški priročniki FDA

FDA Priročnik z navodili za kvantitativno odkrivanje imuno PCR

4. julij 2023

Informacije o izdelku za kvantitativno imuno-PCR detekcijo, ki jo je odobrila FDA Izdelek je kvantitativni imuno-PCR test, zasnovan za odkrivanje ravni IP-10 v plazmi skozi čas. Razvit je bil posebej kot kandidat za farmakodinamični biomarker bioloških zdravil IFN-1, kot je interferon beta-1a…

Blagovna znamka: FDA

FDA Bio-Self Antigen COVID-19 Priročnik z navodili za domači test

22. junij 2023

FDA Bio-Self COVID-19 Antigen Home Test Instruction Manual INTENDED USE The Bio-SelfTM COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription…

Blagovna znamka: FDA

FDA COVI-Go SARS-CoV-2 Ag Priročnik z navodili za samotestiranje

3. april 2023

Informacije o izdelku za samotestiranje FDA COVI-Go SARS-CoV-2 Ag Namenjeno za uporabo z vzorci brisov sprednjega nosu. Samo za dovoljenje za uporabo v nujnih primerih (EUA). Samo za in vitro diagnostično uporabo. Vsebina kompleta vključuje vrečko z odlepljivo folijo, testno napravo, bris za nos in vrečko z zarezo iz folije. Posamezniki…

Blagovna znamka: FDA

FDA ORA-1264078 Priročnik za uporabo balističnih vložkov iz trdih plošč

25. marec 2023

The Food and Drug Administration, Office of Regulatory Affairs (FDA, ORA) FDA/ORA OHAFO Division of Domestic Human and Animal Food Operations  Request for Quotation: FDA-ORA-1264078  Hard Plates Ballistic Inserts  March 2023 Response Date: Date: March 13, 2023 1:00 p.m. Eastern…

Blagovna znamka: FDA

Priročnik z navodili za politiko programa Centra za veterinarsko medicino FDA 1243.5741

25. marec 2023

1243.5741 Center For Veterinary Medicine Program Policy Instruction Manual CENTER FOR VETERINARY MEDICINE PROGRAM POLICY AND PROCEDURES MANUAL MEMORANDUM RECOMMENDING APPROVAL (MRA) FOR ORIGINAL AND SUPPLEMENTAL (ABBREVIATED) NEW ANIMAL DRUG APPLICATIONS ((A)NADA) PURPOSE This document provides instructions on how to…

Blagovna znamka: FDA

FDA DAYVIGO Tablet Navodila za uporabo

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…

Blagovna znamka: FDA

Priročnik z navodili za hitri domači test FDA Assure-100 za COVID-19

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…

Blagovna znamka: FDA

FDA CVM eSubmitter Data Book Uporabniški priročnik

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,…

Blagovna znamka: FDA

FDA CVM eSubmitter Master File Uporabniški priročnik

25. november 2022

FDA CVM eSubmitter Master File Uvod Mojster File Knjiga ponuja sredstvo za shranjevanje Mojstra File information to be reused across submissions and associated books. Reusing this data makes building a submission more efficient, as well as ensuring data…

Blagovna znamka: FDA

Priročnik z navodili FDA za nano test COVID-19

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…

Blagovna znamka: FDA