Identity
- Trade Name
- Tina-quant Albumin Gen.2 FDA UDI
- Generic Name
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 08056722190 FDA UDI
Identifiers
- Catalog Number
- 08056722190 FDA UDI
- Primary DI / UDI-DI
- 07613336120965 FDA UDI
- 510(k) Number
- K101203 FDA UDI
- FDA Product Code
- JIR FDA UDI
- GMDN Term
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1645 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
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: Albumin IVD, kit, nephelometry/turbidimetry
Tina-quant Albumin Gen.2 by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Albumin IVD, kit, nephelometry/turbidimetry.
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- Microalbuminuria Kit (Immunoturbidimetric Method) — Medicalsystem Biotechnology Co., Ltd. · Class II
Cleared under the same submission
K101203 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 I | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 6afcb9f3-9871-4de9-b72e-fa950d10757b 35 fields · synced Jun 7, 2026