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MedTest DX Total Protein for the BS480
FDA UDIClass II (US FDA UDI)
by Medtest DX
Identity
- Trade Name
- MedTest DX Total Protein for the BS480 FDA UDI
- Generic Name
- Total protein IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of total protein concentration in serum using the Mindray BS-480 analyzer. 8 x 60ml. FDA UDI
- Model / Reference
- TP480 FDA UDI
- Description
- For the quantitative determination of total protein concentration in serum using the Mindray BS-480 analyzer. 8 x 60ml. FDA UDI
Identifiers
- Catalog Number
- TP480 FDA UDI
- Primary DI / UDI-DI
- 00817439021281 FDA UDI
- FDA Product Code
- CEK FDA UDI
- GMDN Term
- Total protein IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1635 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MedTest DX Total Protein for the BS480 by Medtest DX — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtest DX
Sources (1)
- FDA UDI e9d10126-5fec-4679-bc17-18e6e0990cb5 37 fields · synced Jun 1, 2026