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Ace SA1004

by Alfa Wassermann, Inc.

Ace SA1004 is a Class II device made by Alfa Wassermann, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00857969006228), 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 Number00857969006228 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  • Withdrawn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
Total amylase IVD, reagent
Model / Ref / Catalog
SA1004
Primary DI / UDI-DI
00857969006228
FDA product code
CIJ
GMDN term
Total amylase IVD, reagent
Device class
Class II
Regulation number
862.1070
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total amylase IVD, reagent

Similar devices

Other devices filed under FDA product code CIJ (Saccharogenic, Amylase).

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)