RealTime 8L07-50
RealTime 8L07-50 is a Class II device made by Abbott Molecular, cleared under FDA 510(k) K140354 on 9 May 2014 and listed in FDA GUDID since 10 Sep 2016 (UDI-DI 00884999037298), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00884999037298 | Date10 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140354 | Date9 May 2014 | StatusActive |
Official records
- AccessGUDID record 00884999037298
- FDA 510(k) database K140354
Across registries
- FDA 510(k) K140354 decided 9 May 2014 Active
- FDA GUDID UDI-DI 00884999037298 listed 10 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140354
- Listed FDA GUDID 00884999037298
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RealTime
- Generic name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
- Model / Ref / Catalog
- 8L07-50
- Primary DI / UDI-DI
- 00884999037298
- 510(k) Number
- FDA product code
- LSL, LIO, MKZ
- GMDN term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
- Device class
- Class II
- Regulation number
- 866.3390, 866.2900, 866.3120
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).