Ace

FDA UDI

Class II (US FDA UDI)

by Alfa Wassermann, Inc.

Identity

Trade Name: ACE FDA UDI
Generic Name: Calcium (Ca2+) IVD, reagent FDA UDI
Device Name: Calcium-Arsenazo Reagent FDA UDI
Model / Reference: SA1009 FDA UDI
Description: Calcium-Arsenazo Reagent FDA UDI

Identifiers

Catalog Number: SA1009 FDA UDI
Primary DI / UDI-DI: 00857969006105 FDA UDI
FDA Product Code: CJY FDA UDI
GMDN Term: Calcium (Ca2+) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1145 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Calcium (Ca2+) IVD, reagent

Ace by Alfa Wassermann, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Alfa Wassermann, Inc.

Sources (1)

FDA UDI 5ac02df9-d1f0-4f8d-b50a-52f74232a099 36 fields · synced Jun 8, 2026