Vitros 8112724
Vitros 8112724 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 23 Aug 2016 (UDI-DI 10758750004393), registry data as of 23 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 | Number10758750004393 | Date23 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 10758750004393
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Total amylase IVD, reagent
- Model / Ref / Catalog
- 8112724
- Primary DI / UDI-DI
- 10758750004393
- FDA product code
- CIW
- GMDN term
- Total amylase IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1070
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code CIW (STARCH-DYE BOUND POLYMER, AMYLASE).
- DMA Amylase Procedure by Data Medical Associates, Inc.
- OLYMPUS AMYLASE REAGENT by Olympus Corp.
- PHADEBAS ISOAMYLASE TEST by Pharmacia, Inc.
- ENZYMATIC ALPHA-AMYLASE REAGENT KIT by Bio-Analytics Laboratories, Inc.
- KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) by EASTMAN KODAK COMPANY
- PANTRAK E.K. by Calbiochem-Behring Corp.
- UNITEST AMYLASE by Boehringer Mannheim Corp.
- Amylase Test (Amyl) Item Number 65653 by Em Diagnostic Systems, Inc.