Aspartate Aminotransferase Reagent
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- Aspartate Aminotransferase Reagent EUDAMEDSynchron FDA UDI
- Generic Name
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Aspartate Aminotransferase Reagent EUDAMEDAspartate Aminotransferase Reagent (AST- 2 x 100) FDA UDI
- Model / Reference
- 467849 EUDAMEDFDA UDI
- Description
- Aspartate Aminotransferase Reagent (AST- 2 x 100) FDA UDI
Identifiers
- Catalog Number
- 467849 FDA UDI
- Primary DI / UDI-DI
- D-467849S4 EUDAMED15099590575076 FDA UDI
- Basic UDI-DI
- B-467849S4 EUDAMED
- 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 IVD General 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Total aspartate aminotransferase (AST) IVD, reagent
Aspartate Aminotransferase Reagent by Beckman Coulter, Inc. — Class IVD General — IVDD, 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
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-467849S4 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 548f42d2-1d7b-4f5e-b716-0a9aa0eaaa3f 61 fields · synced Jun 18, 2026
- FDA UDI 01ee52f8-bfee-4922-a4ec-b4c2479047ec 34 fields · synced May 30, 2026