Amplim A8186
by Amplim, LLC
Amplim A8186 is a Class II device made by Amplim, LLC, listed in FDA GUDID since 26 May 2025 (UDI-DI 00810477026713), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810477026713 | Date26 May 2025 | StatusListed |
Official records
- AccessGUDID record 00810477026713
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Amplim
- Generic name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Model / reference
- A8186
- Primary DI / UDI-DI
- 00810477026713
- 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
- In Commercial Distribution
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