Identity
- Trade Name
- Alanine Aminotransferase (ALT) Test Kit (IFCC) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, reagent FDA UDI
- Device Name
- Alanine Aminotransferase (ALT) Test Kit (IFCC) EUDAMED
- Model / Reference
- R1:80mL×2 R2:20mL×2(706) EUDAMEDR1:80mL×2 R2:20mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674862093 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674862093 EUDAMED
- FDA Product Code
- CKA FDA UDI
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
- GMDN Term
- Alanine aminotransferase (ALT) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1030 FDA UDI
- Market of Registration
- Germany 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
No
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
Prescription Use
No
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: Alanine aminotransferase (ALT) IVD, reagent
Biobase by Biobase Biodustry(Shandong)Co., Ltd. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong)Co., Ltd.
Sources (2)
- FDA UDI f1736103-613c-405d-a125-764e2a6faa7f 32 fields · synced Aug 2, 2026
- EUDAMED 4423823e-1c04-4cba-86a7-8db06216a8ab 61 fields · synced Aug 2, 2026