Albumin ALB505
by Medtest DX
Albumin ALB505 is a Class II device made by Medtest DX, listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00817439020109), not in commercial distribution (GUDID) 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 | Number00817439020109 | Date27 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00817439020109
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Albumin
- Generic name
- Albumin IVD, kit, spectrophotometry
- Model / Ref / Catalog
- ALB505
- Description
- For the quantitative in vitro determination of Albumin in serum and plasma on the Polychem 180 analyzer. 9 x 51 ml
- Primary DI / UDI-DI
- 00817439020109
- FDA product code
- CIX
- GMDN term
- Albumin IVD, kit, spectrophotometry
- Device class
- Class II
- Regulation number
- 862.1035
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code CIX (Bromcresol Green Dye-Binding, Albumin).
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- Analytes Albumin, Total Bilirubin, AST, ALT GEN2 S by Technicon Instruments Corp.