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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 FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817439020109 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

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).

Other devices from Medtest DX

See all devices from Medtest DX →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)