Priročniki in uporabniški priročniki FDA

Uporabniški priročnik za registracijo živilskega obrata FDA

29. avgust 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…

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FDA CVM eSubmitter ADMS Book Electronic Submission Software User Guide

23. julij 2022

CVM eSubmitter Animal Drug and Manufacturing (ADMS) Book Quick Guide Uvod Ta vodnik opisuje funkcije, povezane z viewing and managing establishment information and supply chains in the Animal Drugs and Manufacturing System, or  ADMS, database. The ADM's establishments list…

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FDA SGR 129 Uporabniški priročnik za nevarnosti in nadzor rib in ribiških proizvodov

20. julij 2022

FDA SGR 129 Fish and Fishery Products Hazards and Controls Additional copies may be purchased from: Florida Sea Grant IFAS - Extension Bookstore University of Florida P.O. Box 110011 Gainesville, FL 32611-0011 (800) 226-1764 www.ifasbooks.com  Copies of this guidance document…

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Priročnik za uporabo kompleta za hitri test za COVID-100 FDA ASSURE-19

19. maj 2022

FDA ASSURE-100 Rapid COVID-19 Test Kit Instructions for Use ASSURE-100 Rapid COVID-19 Test Kit Oceanit Foundry LLC For use under an Emergency Use Authorization (EUA) only. For use with nasal swab specimens. For in vitro diagnostic (IVD) use only Rx…

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FDA CovAb SARS-CoV-2 Ab Test Kit Navodila

27. april 2022

CovAb SARS-CoV-2 Ab Test Kit CovAbTM SARS-CoV-2 Ab Test For Emergency Use Authorizat io n (EUA) only For prescriptio n use only For in vitro diagnostic use only Version 3.0 INTENDED USE The CovAbTM SARS-CoV-2 Ab Test is a lateral-flow…

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Navodila za komplet za zbiranje testnega sistema za testiranje protiteles, ki ga sami zbirajo FDA COVID-19

24. februar 2022

Navodila za uporabo samo za uporabo na recept Za uporabo pri posameznikih, starih 19 let ali več, ali pri odraslih, ki zbirajo vzorce od posameznikov, starih 18 let ali več Slabo odvzeta kriampje…

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Priročnik za uporabo FDA SynergyDx Home Collection Kit za COVID-19

20. februar 2022

FDA SynergyDx Home Collection Kit for COVID-19   Before you begin your collection: Please confirm FedEx is operating on a normal service schedule. Please confirm all kit components are included. The use of gloves [not included] is recommended. Wash your…

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Navodila za DTC kompleta za domače zbiranje testov FDA COVID-19

23. januar 2022

FDA test za COVID-19 Test Home Collection Kit DTC E-pošta: covid19@everlywell.com Brezplačno: +1 855-463-1670 CLIA-certificirani laboratorijski partnerji FDA POOBLAŠČENI Physician-reviewed test results, fast and easy-to-read results, all from the comfort of your home. IVD  For Use Under Emergency Use Authorization www.everlywell.com…

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Navodila za komplet za zbiranje SARS-CoV-2 FDA Mount Sinai

18. januar 2022

Navodila za komplet za zbiranje SARS-CoV-2 FDA Mount Sinai Opozorila in previdnostni ukrepi Preberite vsa navodila, preden začnete zbirati vzorec sline. Morate identificirati sample drop-off location and drop-off schedule from the kit registration online portal before you start collecting saliva…

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Navodila FDA Contegra za pljučno ventil H020003

21. september 2021

Contegra® Pulmonary Valved Conduit H020003 Presentation to the Pediatric Advisory Committee September 12, 2017 Dora Vega, MD, PhD Division of Epidemiology Office of Surveillance and Biometrics Center for Devices & Radiological Health Device Description A glutaraldehyde-crosslinked, heterologous bovine jugular vein…

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