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Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA FDA UDI
- Generic Name
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments FDA UDI
- Model / Reference
- FCCP600 FDA UDI
- Description
- The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments FDA UDI
Identifiers
- Catalog Number
- FCCP600 FDA UDI
- Primary DI / UDI-DI
- 05055845400497 FDA UDI
- 510(k) Number
- K110296 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
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: Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)
Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA by Axis-Shield Diagnostics Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA).
- Elecsys Anti-CCP — Roche Diagnostics Corp. · Class II
- IMMUNOSCAN CCPlus — Euro-Diagnostica AB · Class II
- Kallestad — Bio-Rad Laboratories · 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 |
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Manufacturer
- Manufacturer
- Axis-Shield Diagnostics Limited
Sources (1)
- FDA UDI 1f463284-7628-4cc7-8a56-e4128bb507d2 37 fields · synced Jun 6, 2026