Identity
- Trade Name
- QuanTtest Human Protein Standards Set FDA UDI
- Generic Name
- Total protein IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl. FDA UDI
- Model / Reference
- 3410-02 FDA UDI
- Description
- QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl. FDA UDI
Identifiers
- Catalog Number
- 3410-02 FDA UDI
- Primary DI / UDI-DI
- M0513410021 FDA UDI
- 510(k) Number
- K853932 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 Human Protein Standards Set by Quantimetrix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
K853932 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 4ccab6f5-c3c5-4013-a601-044f77f5dc21 37 fields · synced Jun 8, 2026