DG health One Step Pregnancy Test
DG health One Step Pregnancy Test, a total human chorionic gonadotropin IVD (FDA Class II; FDA product code LCX, Kit, Test, Pregnancy, Hcg, Over The Counter) made by Dolgencorp, LLC, was cleared under FDA 510(k) K210341 on 10 Mar 2022 and listed in FDA GUDID on 27 Oct 2023 (UDI-DI 00751774250787); the registry lists it as not in commercial distribution (GUDID) 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 | Number00751774250787 | Date27 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210341 | Date10 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 00751774250787
- FDA 510(k) database K210341
Across registries
- FDA 510(k) K210341 decided 10 Mar 2022 Active
- FDA GUDID UDI-DI 00751774250787 listed 27 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K210341
- Listed FDA GUDID 00751774250787
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DG health
- Generic name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- One Step Pregnancy Test
- Primary DI / UDI-DI
- 00751774250787
- 510(k) Number
- FDA product code
- LCX
- GMDN term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical.