RealTime 08L21-66
RealTime 08L21-66 is a Class II device made by Abbott Molecular, approved under FDA PMA P120012 on 20 Jun 2013 and listed in FDA GUDID since 20 Nov 2014 (UDI-DI 00884999036444), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00884999036444 | Date20 Nov 2014 | StatusListed |
| United States | FDA PMAAPRL | NumberP120012 | Date20 Jun 2013 | StatusActive |
Official records
- AccessGUDID record 00884999036444
- FDA PMA database P120012
Across registries
- FDA PMA P120012 decided 20 Jun 2013 Active
- FDA GUDID UDI-DI 00884999036444 listed 20 Nov 2014 Listed
Timeline
- Approved FDA PMA P120012
- Listed FDA GUDID 00884999036444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- RealTime
- Generic name
- DNA anti-contamination enzyme reagent IVD
- Model / Ref / Catalog
- 08L21-66
- Primary DI / UDI-DI
- 00884999036444
- PMA number
- FDA product code
- OBF
- GMDN term
- DNA anti-contamination enzyme reagent IVD
- Device class
- Class II
- Regulation number
- 866.3170
- GUDID distribution status
- In Commercial Distribution