Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, reagent FDA UDI
- Device Name
- ALT Reagent FDA UDI
- Model / Reference
- SA1046 FDA UDI
- Description
- ALT Reagent FDA UDI
Identifiers
- Catalog Number
- SA1046 FDA UDI
- Primary DI / UDI-DI
- 00857969006556 FDA UDI
- 510(k) Number
- K113382 FDA UDI
- FDA Product Code
- CKA FDA UDI
- GMDN Term
- Alanine aminotransferase (ALT) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alanine aminotransferase (ALT) IVD, reagent
Ace by Alfa Wassermann, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, reagent.
- ALT (SGPT) LIQUID REAGENT (KINETIC METHOD) — TECO DIAGNOSTICS · Class I
- GPT LIQUID R1:4x36, R2:2x18 ml (GSAU) — Biotechnological Applications Ltd · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Alinity — Abbott · Class I
Cleared under the same submission
K113382 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI a325165d-e035-4f31-9596-2f40acac8e11 37 fields · synced May 30, 2026