FDA.reportPublic FDA data

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

Primary DI
05055845400497
Brand
Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA
Company
AXIS-SHIELD DIAGNOSTICS LIMITED
Model
FCCP600
Catalog number
FCCP600
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
Published
2019-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110296000AXIS-SHIELD ANTI-CCPAxis-Shield Diagnostics, Ltd.2011-08-18NHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055845400497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055845400497050558454004975055845400497

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1-877-441-7440USproductsupport@abbott.com

Regulatory Flags#

DUNS number
229062427
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)04S792104S79212025-02-26
05055845400008Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAFCCP600FCCP6002016-09-01
05055845400015Axis® Homocysteine EIAFHCY100FHCY1002016-06-13
05055845400022Axis-Shield Homocysteine ControlsFHCY200FHCY2002016-07-01
05055845400046Axis-Shield Active-B12 (Holotranscobalamin) EIAFMABT100FMABT1002016-09-02
050558454000843-Reagent Homocysteine Assay for SYNCHRON UniCelFHYB100/B08175FHYB100/B081752016-07-01
05055845400169Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR100FHRWR1002016-07-01
05055845400176Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR200FHRWR2002016-07-01
05055845400183Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR1000FHRWR10002016-07-01
05055845400282Axis-Shield Liquid Stable (LS) 2-Part Homocysteine ReagentFHBC100/B08176FHBC100/B081762016-07-01
05055845400527Alere NT-proBNP for Alinity Control Kit04S791104S79112025-02-27
05055845400534Alere NT-proBNP for Alinity Calibrator Kit04S790204S79022025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066015798EliA CCP WellPhadia ABNHX2026-01-29
07333066024202EliA IgG Calibrator WellPhadia ABNHX2026-01-29
07333066024226EliA Dummy WellPhadia ABNHX2026-01-29
07333066015507EliA CCP WellPhadia ABNHX2026-01-29
07333066023908EliA IgG Calibrator WellPhadia ABNHX2026-01-29
07333066023939EliA Dummy WellPhadia ABNHX2026-01-29
07333066020907Phadia 5000EPhadia ABNHX2020-12-01
07333066020914Phadia 5000E+EPhadia ABNHX2020-12-01
07333066020921Phadia 2500EPhadia ABNHX2020-12-01
07333066020938Phadia 2500EEPhadia ABNHX2020-12-01
03610522053131BioPlex 2200BIO-RAD LABORATORIES, INC.NHX2019-11-27
07333066020020EliA CCP Positive Control 2500/5000Phadia ABNHX2019-03-29
07333066014173EliA CCP Positive Control 2500/5000Phadia ABNHX2019-03-29
07333066020051EliA IgG CalibratorsPhadia ABNHX2019-03-26
07333066001036Dilution Plate, Phadia 250Phadia ABNHX2019-02-20
00380740151362AlinityAbbott GmbHNHX2018-12-04
00630414245669Atellica IM aCCPSiemens Healthcare Diagnostics Inc.NHX2018-10-19
04049016026853Anti-CCP ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNHX2016-09-24
00630414592312ADVIA Centaur® aCCP IgGSiemens Healthcare Diagnostics Inc.NHX2016-09-24
00630414601991IMMULITE® 2000 Systems CCP Anti-CCP IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNHX2016-09-24
07333066012629EliA IgG ConjugatePhadia ABNHX2016-09-23
07333066012636EliA Sample DiluentPhadia ABNHX2016-09-23
07333066012704EliA IgG Curve ControlPhadia ABNHX2016-09-23
07333066012797EliA IgG Calibrator StripPhadia ABNHX2016-09-23
07333066012803EliA IgG Curve Control StripPhadia ABNHX2016-09-23
07333066012810EliA IgG Conjugate 50Phadia ABNHX2016-09-23
07333066012827EliA IgG Conjugate 200Phadia ABNHX2016-09-23
07333066012872EliA Sample DiluentPhadia ABNHX2016-09-23
07333066013015EliA CCP Positive Control 250Phadia ABNHX2016-09-23
07333066013060EliA CCP Positive Control 100Phadia ABNHX2016-09-23