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Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA

FDA UDI

Class II (US FDA UDI)

by Axis-Shield Diagnostics Limited

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
05055845400008 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
Not 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

Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA by Axis-Shield Diagnostics Limited — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K110296 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axis-Shield Diagnostics Limited

Sources (1)

  • FDA UDI c2943299-c90b-46f5-bfc6-375b1a8ead47 38 fields · synced May 30, 2026