AccessGUDID - DEVICE: Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA (05055845400008)

GUDID

Device Identifier (DI) Information

Brand Name: Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA
Version or Model: FCCP600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FCCP600
Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED

Primary DI Number: 05055845400008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 229062427 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54896	Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide antibody (CCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110296	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c2943299-c90b-46f5-bfc6-375b1a8ead47
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016