Recognized standard
NBS01-A6 (Replaces LA04-A5)
FDA recognition 7-244 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-244 |
|---|---|
| Designation | NBS01-A6 (Replaces LA04-A5) |
| Title | Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This document highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: