Mitochondrial Aspartate aminotransferase (mAST) Test Kit (Enzyme Inhibition)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- Mitochondrial Aspartate aminotransferase (mAST) Test Kit (Enzyme Inhibition) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Total aspartate aminotransferase (AST) IVD, reagent FDA UDI
- Device Name
- Mitochondrial Aspartate aminotransferase (mAST) Test Kit (Enzyme Inhibition) EUDAMED
- Model / Reference
- Calibrator：1mL×1（91055） EUDAMEDR1:25mL×1 R2:10mL×1（702） EUDAMEDR1:25mL×1 R2:10mL×1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674868125 EUDAMED06971674869184 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674868125 EUDAMEDB-06971674869184 EUDAMED
- FDA Product Code
- CIT FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER 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
- Not 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: Nucleic acid extraction/isolation kit IVD
Mitochondrial Aspartate aminotransferase (mAST) Test Kit (Enzyme Inhibition) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD, FDA UDI…
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Also classified as Nucleic acid extraction/isolation kit IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674868125 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED f3ceccb8-6d13-466b-86e4-381883c1206b 61 fields · synced Oct 6, 2026
- EUDAMED 6fa7c712-fb30-4212-9434-daa9e148964b 61 fields · synced May 19, 2026
- FDA UDI 48c78d56-8d4d-42f1-a02e-bf58a04c75a2 33 fields · synced May 29, 2026