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Total Protein (TP) Test Kit (Biuret)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref R:50mL×4（791）
Identity
- Trade Name
- Total Protein (TP) Test Kit (Biuret) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Total protein IVD, reagent FDA UDI
- Device Name
- Total Protein (TP) Test Kit (Biuret) EUDAMED
- Model / Reference
- R:50mL×4（791） EUDAMEDR:50mL×4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674862314 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674862314 EUDAMED
- FDA Product Code
- CEK FDA UDI
- EMDN Code
- W01010230 TOTAL PROTEIN EUDAMED
- GMDN Term
- Total protein IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1635 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
Total Protein (TP) Test Kit (Biuret) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674862314 | 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 (2)
- EUDAMED a7e547fd-fb43-414f-b716-66dc47428740 61 fields · synced Jun 17, 2026
- FDA UDI 1bf49c2d-a398-46b1-a8d7-13aee97bead4 32 fields · synced May 29, 2026