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Creatinine Reagent Set R1 x 500mL, R2 x 125mL

by Clinical Diagnostic Solutions, Inc.

Creatinine Reagent Set R1 x 500mL, R2 x 125mL (501-409) is a Class II device made by Clinical Diagnostic Solutions, Inc., listed in FDA GUDID since 12 Oct 2016 (UDI-DI 00812137011961), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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 Number00812137011961 UDI-DI Date12 Oct 2016ListedStatusListed GUDID: 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  • Withdrawn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
Creatinine Reagent Set
Generic name
Creatinine IVD, reagent
Model / Ref / Catalog
R1 x 500mL, R2 x 125mL, 501-409
Primary DI / UDI-DI
00812137011961
FDA product code
CGX
GMDN term
Creatinine IVD, reagent
Device class
Class II
Regulation number
862.1225
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine).

Other devices from Clinical Diagnostic Solutions, Inc.

See all devices from Clinical Diagnostic Solutions, Inc. →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)