Identity
- Trade Name
- Total Protein LiquiColor® FDA UDI
- Generic Name
- Total protein IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the Quantitative Colorimetric Determination of Total Protein in Serum. FDA UDI
- Model / Reference
- 0250-500 FDA UDI
- Description
- For the Quantitative Colorimetric Determination of Total Protein in Serum. FDA UDI
Identifiers
- Catalog Number
- 0250-500 FDA UDI
- Primary DI / UDI-DI
- 00657498000991 FDA UDI
- FDA Product Code
- CEK FDA UDI
- GMDN Term
- Total protein IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1635 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total protein IVD, kit, spectrophotometry
Total Protein LiquiColor® by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total protein IVD, kit, spectrophotometry.
- TOTAL PROTEIN (TP) — Randox Laboratories, Ltd. · Class II
- ADVIA® Chemistry TP Total Protein II Reagents — Siemens Healthcare Diagnostics · Class II
- TOTAL PROTEIN — Sekisui Diagnostics, LLC · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® TP RGT. KIT BL-217 — Carolina Liquid Chemistries Corp. · Class II
- TOTAL PROTEIN 2 (TP 2) — Randox Laboratories, Ltd. · Class II
- Dimension Vista® Flex® reagent cartridge TP — Siemens Healthcare Diagnostics · Class II
- TOTAL PROTEIN (UP) — Randox Laboratories, Ltd. · Class I
- Atellica™ CH TP — Siemens Healthcare Diagnostics · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI f7589d7b-97b1-4a38-b398-7dd901520f6e 36 fields · synced May 30, 2026