Recognized standard
NBS01 7th Edition
FDA recognition 7-316 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-316 |
|---|---|
| Designation | NBS01 7th Edition |
| Title | Dried Blood Spot Specimen Collection for Newborn Screening |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard describes the collection of blood specimens for newborn screening (NBS) programs, including equipment, sources of blood, collection sites, and techniques for blood spot specimen collection. This standard is intended to improve and ensure the quality of dried blood spot (DBS) specimens… |
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: