Identity
- Trade Name
- Optilite C3c Kit FDA UDI
- Generic Name
- Complement components C3/C3c IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK023.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700017596 FDA UDI
- 510(k) Number
- K100179 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
Yes
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: Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
Optilite C3c Kit by The Binding Site Group — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Complement components C3/C3c IVD, kit, nephelometry/turbidimetry.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI 2b414d3d-45d4-4f62-8411-bfc6ec56e1bf 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026