Exact Diagnostics HBVL201
Exact Diagnostics HBVL201 is a Class II device made by Exact Diagnostics, listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00812242030680), 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 | Number00812242030680 | Date24 Sep 2018 | StatusListed |
Official records
- AccessGUDID record 00812242030680
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Exact Diagnostics
- Generic name
- Hepatitis B virus nucleic acid IVD, calibrator
- Model / Ref / Catalog
- HBVL201
- Primary DI / UDI-DI
- 00812242030680
- FDA product code
- JIT
- GMDN term
- Hepatitis B virus nucleic acid IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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