Identity
- Trade Name
- AST EUDAMEDAU FDA UDI
- Generic Name
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry FDA UDI
- Device Name
- AST EUDAMEDFDA UDI
- Model / Reference
- OSR6109 EUDAMEDFDA UDI
- Description
- AST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590010089 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995901OSR6109M5 EUDAMED
- 510(k) Number
- K925155 FDA UDI
- FDA Product Code
- CIT FDA UDI
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
- GMDN Term
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1100 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Category: Total aspartate aminotransferase (AST) IVD, reagent
Ast by Beckman Coulter, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total aspartate aminotransferase (AST) IVD, reagent.
- GOT (AST) — Cypress Diagnostics · IVD General
- ASPARTATE AMINOTRANSFERASE REAGENT KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- AST (SGOT) Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- GOT LIQUID R1:4x40, R2:2x20 ml (ΗΙΤ) — Biotechnological Applications Ltd · IVD General
- Aspartate Aminotransferase Kit( IFCC Method) — Coei Biotech Co.Ltd. · IVD General
- Aspartate Aminotransferase (AST) — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995901OSR6109M5 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED fc4c7a29-899a-4154-a243-45834febb282 61 fields · synced Oct 6, 2026
- FDA UDI c1beba63-ad51-44ea-90a9-e40a10567634 34 fields · synced May 30, 2026