Identity
- Trade Name
- ADVIA® Chemistry C3 Complement C3 Reagents FDA UDI
- Generic Name
- Complement components C3/C3c IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- C3 - ADVIA Chem. - RGT - 2x100 tests FDA UDI
- Model / Reference
- 10309053 FDA UDI
- Description
- C3 - ADVIA Chem. - RGT - 2x100 tests FDA UDI
Identifiers
- Catalog Number
- 3060444 FDA UDI
- Primary DI / UDI-DI
- 00630414517735 FDA UDI
- 510(k) Number
- K000469 FDA UDI
- FDA Product Code
- CZW FDA UDI
- GMDN Term
- Complement components C3/C3c IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5240 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
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: Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
ADVIA® Chemistry C3 Complement C3 Reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Complement components C3/C3c IVD, kit, nephelometry/turbidimetry.
- Tinaquant Complement C3c ver2 — Roche Diagnostics Corp. · Class II
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- Optilite C3c Kit — The Binding Site Group · Class II
- N Antiserum to Human C3c — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Tina-quant Complement C3c Ver.2 — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
- Alinity — ABBOTT IRELAND · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
Cleared under the same submission
K000469 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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 138602dc-16eb-427e-8559-e5b8ce5aef8f 37 fields · synced Jun 1, 2026