Finder 100-000009
by Baebies Inc.
Finder 100-000009 is a Class II device made by Baebies Inc., cleared under FDA 510(k) K201049 on 14 Sep 2022 and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 00819704020340), 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 | Number00819704020340 | Date31 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201049 | Date14 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 00819704020340
- FDA 510(k) database K201049
Across registries
- FDA 510(k) K201049 decided 14 Sep 2022 Active
- FDA GUDID UDI-DI 00819704020340 listed 31 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K201049
- Listed FDA GUDID 00819704020340
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Finder
- Generic name
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence
- Model / reference
- 100-000009
- Description
- FINDER G6PD Test (Box of 16)
- Primary DI / UDI-DI
- 00819704020340
- 510(k) Number
- FDA product code
- JBF
- GMDN term
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence
- Device class
- Class II
- Regulation number
- 864.7360
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening).