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Aspartate Aminotransferase Kit (Colorimetric Method )
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Aspartate Aminotransferase Kit (Colorimetric Method ) FDA UDI
- Generic Name
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- None FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970291985154 FDA UDI
- FDA Product Code
- CIT FDA UDI
- GMDN Term
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1100 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Aspartate Aminotransferase Kit (Colorimetric Method ) by Medicalsystem Biotechnology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Medicalsystem Biotechnology Co., Ltd.
Sources (1)
- FDA UDI 355db410-1462-411e-8e04-bc7cf629a6dd 32 fields · synced May 30, 2026