Exact Diagnostics HBVP100
Exact Diagnostics HBVP100 is a Class II device made by Exact Diagnostics, listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00812242030116), 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 | Number00812242030116 | Date24 Sep 2018 | StatusListed |
Official records
- AccessGUDID record 00812242030116
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- Withdrawn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
- HBVP100
- Primary DI / UDI-DI
- 00812242030116
- 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
Similar devices
Other devices filed under FDA product code JIT (Calibrator, Secondary).
- ELECSYS CEA ASSAY by Boehringer Mannheim Corp.
- Diazyme DZ179A-CAL by Diazyme Laboratories, Inc.
- DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D by DIAMOND DIAGNOSTICS Inc
- Dimension® RCRP CAL 10445026 DC34 by Siemens Healthcare Diagnostics Inc.
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR100 by Axis-Shield Diagnostics Limited
- OXALATE URINE CONTROLS (NORMAL AND ELEVATED) by Thermo-Electron Corp.
- Dimension® ENZ II CAL 10476170 DC143 by Siemens Healthcare Diagnostics Inc.
- ARCHITECT 2K47-27 02K4727 by Abbott Ireland Diagnostics
- Diazyme DZ147A-CAL by Diazyme Laboratories, Inc.
- CALIBRATING MATERIAL, BUFFERS, STANDARD by Mission Diagnostics