Biobase
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Aspartate Aminotransferase (AST) Test Kit (Aspartate) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Total aspartate aminotransferase (AST) IVD, reagent FDA UDI
- Device Name
- Aspartate Aminotransferase (AST) Test Kit (Aspartate) EUDAMED
- Model / Reference
- R1:64mL×6 R2:48mL×2(795) EUDAMEDR1:64mL×6 R2:48mL×2（795） EUDAMEDR1:64mL×6 R2:48mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674861973 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674861973 EUDAMED
- FDA Product Code
- CIT FDA UDI
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
- GMDN Term
- Total aspartate aminotransferase (AST) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1100 FDA UDI
- Market of Registration
- Germany 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Total aspartate aminotransferase (AST) IVD, reagent
Biobase by Biobase Biodustry(Shandong)Co., Ltd. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · IVD General
- Calcium Assay Kit (Arsenazo III Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong)Co., Ltd.
Sources (2)
- FDA UDI 57483a21-b3ae-4532-aa91-70c39385e275 32 fields · synced Jul 23, 2026
- EUDAMED be8cd2ba-f1fd-4339-8948-d29164cd53e5 61 fields · synced Jul 23, 2026