FDA käsiraamatud ja kasutusjuhendid

FDA 2024 CE haruldaste haiguste päeva krediidinõude juhised

11. märts 2024

FDA 2024 CE Rare Disease Day Credit Claiming CE Credit Claiming Instructions *Must be completed by March 15, 2024 Step 1: Log in to the CE Portal Go to https://ceportal.fda.gov FDA Employees – sign in with single sign-on Non-FDA Participants-…

Kaubamärk: FDA

FDA K230087 Point Kinguide Agile hübriidnavigatsioonisüsteemi juhised

23. veebruar 2024

FDA K230087 Point Kinguide Agile Hybrid Navigation System Product Information Specifications Trade/Device Name: POINT Kinguide Agile Hybrid Navigation System Regulation Number: 21 CFR 882.4560 Regulatory Class: Class II Product Code: OLO Product Usage Instructions Indications for Use The POINT Kinguide…

Kaubamärk: FDA

FDA tootejälgimissüsteemi (PTS) kasutusjuhend

22. jaanuar 2024

FDA tootejälgimissüsteemi (PTS) tootejälgimissüsteemi (PTS) spetsifikatsioonid Rakenduse hostimine: Amazon Web Services (AWS) Front End Development: Django Data Analytics & AI/ML: Domino Data Labs & Amazon Sagemaker Data Visualization: Qlik Advancing Food Traceability through Innovation The Product…

Kaubamärk: FDA

FDA AD-0602-Band D vabade töökohtade väljakuulutamise filiaali peakasutusjuhend

21. jaanuar 2024

AD-0602-Band D Vacancy Announcement Branch Chief Title 21 Vacancy Announcement Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) Office of Clinical Evaluation (OCE) Division…

Kaubamärk: FDA

FDA 7500 kiirinstrumendi kasutusjuhend

15. jaanuar 2024

FDA 7500 kiirinstrumendi standardne tööprotseduur – Cyclospora caye tanensis'e molekulaarne tuvastamine värsketes toodetes reaalajas PCR-i abil. Toodete pesemise ja DNA ekstraheerimise protseduurid See analüütiline protseduur pakub samme C. caye tanensis'e ootsüstide eraldamiseks toodetest…

Kaubamärk: FDA

FDA MD-8150 COVID-19 antigeeni kodus testimise juhend

2. jaanuar 2024

MD-8150 COVID-19 Antigen At Home Test Instruction Manual MD-8150 COVID-19 Antigen At Home Test Nano-Check™ COVID-19 Antigen At-Home Test Quick Reference Instruction Catalog No. MD-8150 For Use Under an Emergency Use Authorization(EUA) Only For In Vitro Diagnostic Use, For Use…

Kaubamärk: FDA

FDA 21 vaba töökoha teadaande kasutusjuhend

31. detsember 2023

FDA 21 Vacancy Announcement Product Information Specifications Position: Deputy Office Director Series: AD-0602 Location(s): Silver Spring, Maryland Work Schedule: Full Time Cures Band(s): Band F Salary: Starting at $210,000 Full Performance Band Level: Band F Travel Requirements: 25% or less…

Kaubamärk: FDA

FDA-2023-D-4722 Piima- ja kooretoodete ning jogurti kasutusjuhend

12. detsember 2023

FDA-2023-D-4722 Milk and Cream Products and Yogurt Product Information Specifications Product Name: Milk and Cream Products and Yogurt Products Standards Revoked: Lowfat Yogurt and Nonfat Yogurt Standard Amended: Yogurt Regulatory Authority: Food and Drug Administration (FDA) Regulatory Code: 21 CFR…

Kaubamärk: FDA

FDA TangenDx SARS-CoV-2 molekulaartesti kasutusjuhend

8. detsember 2023

USA TOIDU- JA RAVIMIAMET TangenDx SARS-CoV-2 molekulaartest 29. september 2023 Glenn Neuman RADx regulatiivne konsultant New World Regulatory Solutions, Inc. Esindaja: Tangen Biosciences, Inc. 20 Commercial St. Branford, CT 06405 Seade: TangenDx SARS-CoV-2 molekulaartest EUA number: EUA230015…

Kaubamärk: FDA

FDA hoidmine Webinar toidu jälgitavuse lõpliku reegli kasutusjuhendis

7. detsember 2023

FDA hoidmine Webinar toidu jälgitavuse lõpliku reegli kasutusjuhendist Tere tulemast tänasesse päeva Webinar Thanks for joining us! We’ll get started in a few minutes Today’s Topic: FDA’s Proposed Rule Regarding Laboratory Developed Tests Date: October 31, 2023 Proposed…

Kaubamärk: FDA