Skip to content

Ace RX1012

by Alfa Wassermann, Inc.

Ace RX1012 is a Class II device made by Alfa Wassermann, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00857969006068), 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 Number00857969006068 UDI-DI Date24 Sep 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  • Withdrawn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
Ace
Generic name
Creatinine IVD, reagent
Model / Ref / Catalog
RX1012
Primary DI / UDI-DI
00857969006068
FDA product code
CGX
GMDN term
Creatinine IVD, reagent
Device class
Class II
Regulation number
862.1225
GUDID distribution status
In Commercial Distribution

Related devices

Category: Creatinine IVD, reagent

Similar devices

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

Other devices from Alfa Wassermann, Inc.

See all devices from Alfa Wassermann, Inc. →

Properties

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