Identity
- Trade Name
- C3d Plates & Calibrator Sets FDA UDI
- Generic Name
- Complement components C3/C3c IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- C3DCP FDA UDI
Identifiers
- Catalog Number
- C3DCP FDA UDI
- Primary DI / UDI-DI
- 00813545023836 FDA UDI
- 510(k) Number
- K861362 FDA UDI
- FDA Product Code
- CZW FDA UDI
- GMDN Term
- Complement components C3/C3c IVD, kit, enzyme immunoassay (EIA) 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
Yes
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: Complement components C3/C3c IVD, kit, enzyme immunoassay (EIA)
C3d Plates & Calibrator Sets by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Complement components C3/C3c IVD, kit, enzyme immunoassay (EIA).
- MicroVue — Quidel Corp. · Class II
- Scanlisa C3d Elisa 96 Test — Scimedx Corp. · Class II
Cleared under the same submission
K861362 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
- Scimedx Corp.
Sources (1)
- FDA UDI df7ac61b-f765-409d-9a01-f6969c6b39ce 35 fields · synced May 31, 2026