Identity
- Trade Name
- Tinaquant Ceruloplasmin FDA UDI
- Generic Name
- Ceruloplasmin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 11660497216 FDA UDI
Identifiers
- Catalog Number
- 11660497216 FDA UDI
- Primary DI / UDI-DI
- 04015630906888 FDA UDI
- 510(k) Number
- K062114 FDA UDI
- FDA Product Code
- CHN FDA UDI
- GMDN Term
- Ceruloplasmin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5210 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: Ceruloplasmin IVD, kit, nephelometry/turbidimetry
Tinaquant Ceruloplasmin by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceruloplasmin IVD, kit, nephelometry/turbidimetry.
- Alinity — Abbott Laboratories, Inc. · Class II
- Dimension Vista® Ceruloplasmin Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- N Antiserum to Human Ceruloplasmin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Optilite Caeruloplasmin Kit — The Binding Site Group · Class II
- CERULOPLASMIN (CPL) — Randox Laboratories, Ltd. · Class II
- Ceruloplasmin — Roche Diagnostics Corp. · Class II
- Ceruloplasmin — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K062114 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 5098d245-2822-49b6-b7c7-ad24c553d9a1 35 fields · synced Jun 1, 2026