Identity
- Trade Name
- QuanTtest Red Reagent Total Protein Assay System FDA UDI
- Generic Name
- Total protein IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL). FDA UDI
- Model / Reference
- 2210-02 FDA UDI
- Description
- The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL). FDA UDI
Identifiers
- Catalog Number
- 2210-02 FDA UDI
- Primary DI / UDI-DI
- M0512210021 FDA UDI
- 510(k) Number
- K904603 FDA UDI
- FDA Product Code
- CEK FDA UDI
- GMDN Term
- Total protein IVD, kit, enzyme 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Total protein IVD, kit, enzyme spectrophotometry
QuanTtest Red Reagent Total Protein Assay System by Quantimetrix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total protein IVD, kit, enzyme spectrophotometry.
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- Total Protein UrineCSF Gen3 — Roche Diagnostics Corp. · Class II
- ENVOY 500 TOTAL PROTEIN REAGENT KIT — VITALSCIENTIFIC
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- Total Protein Gen2 monocromatic — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K904603 also covers:
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
- Quantimetrix Corp.
Sources (1)
- FDA UDI 00c153e1-c7f9-446d-8578-6ab36a67be39 37 fields · synced May 30, 2026