✦ LIBER ✦
Analyte specific reagents: FDA final rule and implications for your clinical flow cytometry laboratory
✍ Scribed by Rebecca L. Johnson
- Book ID
- 101243030
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 21 KB
- Volume
- 38
- Category
- Article
- ISSN
- 0196-4763
No coin nor oath required. For personal study only.
✦ Synopsis
the U.S. Food and Drug Administration (FDA) issued a Final Rule classifying/ reclassifying analyte specific reagents (ASRs). The Rule now consistently classifies and regulates previously unclassified pre-1976 reagents and post-1976 reagents that were statutorily classified as Class III devices. This Rule went into effect on November 23, 1998. The Final Rule contains specific requirements that clinical laboratories and manufacturers must follow, which are highlighted below.