FDA අත්පොත් සහ පරිශීලක මාර්ගෝපදේශ

FDA ENSPRYNG මාත්‍රාව සහ Spryng එන්නත් උපදෙස් අත්පොත

25 ඔක්තෝබර් 2023

Instructions for Use ENSPRYNG® (en-spryng) (satralizumab-mwge) Injection Read this Instructions for Use before you start using your prefilled syringe and each time you get a refill. There may be new…

FDA Premarket දුම්කොළ නිෂ්පාදන යෙදුම් පරිශීලක මාර්ගෝපදේශය

4 ඔක්තෝබර් 2023

U.S. Food and Drug Administration Center for Tobacco Products (CTP) Product Form Validator Tool User Guide Document Version Number: 1 September 2023 Introduction The FDA Center for Tobacco Products (CTP)…

FDA උසස් සෞඛ්‍ය වෛද්‍ය උපාංග උපදෙස් අත්පොත

3 සැප්තැම්බර් 2023

EXECUTIVE SUMMARY FOR THE PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING Advancing Health Equity in Medical Devices Disclaimer: This Executive Summary is for discussion purposes only and does not represent draft or…

FDA සෞඛ්‍ය සහ මානව සේවා උපදෙස් දෙපාර්තමේන්තුව

29 අගෝස්තු 2023

FDA Department of Health and Human Services Instructions Title 21 Vacancy Announcement Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Center for Biologics Evaluation and Research…

FDA Optilume BPH කැතීටර් පද්ධති උපදෙස් අත්පොත

12 අගෝස්තු 2023

FDA Optilume BPH Catheter System Product Information The Optilume BPH Catheter System is a medical device designed for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH)…

FDA SurVeil Drug-coated Balloon User Guide

12 අගෝස්තු 2023

FDA SurVeil Drug-Coated Balloon Product Information The SurVeilTM Drug-Coated Balloon is a medical device authorized by Federal (U.S.) law for the treatment of peripheral artery disease (PAD). It is specifically…

FDA මාතෘකාව 21 පුරප්පාඩු නිවේදන උපදෙස්

5 අගෝස්තු 2023

FDA Title 21 Vacancy Announcement Introduction The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs,…

SARS-CoV-19 ප්‍රතිදේහජනක උපදෙස් අත්පොත හඳුනාගැනීම සඳහා FDA Swab-N-Go HomeTest COVID-2 Ag වේගවත් රෝග විනිශ්චය පරීක්ෂණය

24 ජූලි 2023

FDA Swab-N-Go HomeTest COVID-19 Ag Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen Instruction Manual INTENDED USE The Swab-N-Go Home Test COVID-19 Ag is a lateral flow immunoassay intended for…

FDA පියයුරු තැන්පත් කිරීමේ උපදෙස්

22 ජූලි 2023

FDA Breast Implants Product Information: Breast Implants Breast implants are medical devices that are used for breast augmentation, reconstruction, or revision surgery. Before undergoing any breast implant surgery, it is crucial…

FDA Quantitative Immuno PCR හඳුනාගැනීමේ උපදෙස් අත්පොත

4 ජූලි 2023

FDA Quantitative Immuno PCR Detection Product Information The product is a quantitative immuno-PCR assay designed for the detection of plasma IP-10 levels over time. It is specifically developed as a…