RealTime 09N21-070
RealTime 09N21-070 is a Class II device made by Abbott Molecular, approved under FDA PMA P160044 on 18 May 2017 and listed in FDA GUDID since 6 Jun 2017 (UDI-DI 00884999045774), 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 | Number00884999045774 | Date6 Jun 2017 | StatusListed |
| United States | FDA PMAAPRL | NumberP160044 | Date18 May 2017 | StatusActive |
Official records
- AccessGUDID record 00884999045774
- FDA PMA database P160044
Across registries
- FDA PMA P160044 decided 18 May 2017 Active
- FDA GUDID UDI-DI 00884999045774 listed 6 Jun 2017 Listed
Timeline
- Approved FDA PMA P160044
- Listed FDA GUDID 00884999045774
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- RealTime
- Generic name
- Cytomegalovirus (CMV) nucleic acid IVD, calibrator
- Model / Ref / Catalog
- 09N21-070
- Primary DI / UDI-DI
- 00884999045774
- PMA number
- FDA product code
- PAB
- GMDN term
- Cytomegalovirus (CMV) nucleic acid IVD, calibrator
- Device class
- Class II
- Regulation number
- 866.3180
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PAB (Cytomegalovirus (cmv) dna quantitative assay).
- Aptima® CMV, CONTROLS KIT, APTIMA, IVD PRD-05076 by Hologic
- COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST by Roche Molecular System, Inc.
- Aptima® KIT, MAIN ASSAY, CMV, 100-TEST, IVD ASY-12071 by Hologic
- cobas CMV Test by Roche Molecular System, Inc.
- Aptima CMV Quant Assay by Hologic, Inc.
- Artus CMV RGQ MDX Kit by Qiagen, Inc.