Simplexa™ GBS Positive Control Pack MOL3560
Simplexa™ GBS Positive Control Pack MOL3560 is a Class II device made by DiaSorin Molecular LLC, cleared under FDA 510(k) K182467 on 7 Nov 2018 and listed in FDA GUDID since 20 Nov 2018 (UDI-DI 20816101025651), 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 | Number20816101025651 | Date20 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182467 | Date7 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 20816101025651
- FDA 510(k) database K182467
Across registries
- FDA 510(k) K182467 decided 7 Nov 2018 Active
- FDA GUDID UDI-DI 20816101025651 listed 20 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K182467
- Listed FDA GUDID 20816101025651
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Simplexa™ GBS Positive Control Pack
- Generic name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
- Model / Ref / Catalog
- MOL3560
- Primary DI / UDI-DI
- 20816101025651
- 510(k) Number
- FDA product code
- OOI, NJR
- GMDN term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
- Device class
- Class II
- Regulation number
- 862.2570, 866.3740
- GUDID distribution status
- In Commercial Distribution