Identity
- Trade Name
- Kallestad FDA UDI
- Generic Name
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Kallestad Anti-Cyclic Citrullinated Peptides (CCP) II Microplate EIA FDA UDI
- Model / Reference
- 96CP FDA UDI
- Description
- Kallestad Anti-Cyclic Citrullinated Peptides (CCP) II Microplate EIA FDA UDI
Identifiers
- Catalog Number
- 96CP FDA UDI
- Primary DI / UDI-DI
- 00847817000294 FDA UDI
- 510(k) Number
- K062045 FDA UDI
- FDA Product Code
- NHX FDA UDI
- GMDN Term
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 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
Yes
FDA UDI
Category: Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)
Kallestad by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA).
- Elecsys Anti-CCP — Roche Diagnostics Corp. · Class II
- Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA — Axis-Shield Diagnostics Limited · Class II
- IMMUNOSCAN CCPlus — Euro-Diagnostica AB · Class II
- Anti-CCP ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- CCPoint — Euro-Diagnostica AB · Class II
- EL-anti-CCP/2 — THERATEST LABORATORIES, INC.
- EDIA anti-CCP — Euro-Diagnostica AB · Class II
- Elecsys AntiCCP Immunoassay — Roche Diagnostics Corp. · Class II
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI bc9794eb-9a61-4eff-8eb1-fa64a6173f29 38 fields · synced May 30, 2026