FDA.reportPublic FDA data

Alinity

Primary DI
00380740151362
Brand
Alinity
Company
Abbott GmbH
Model
09P2720
Catalog number
09P2720
Device description
Alinity i Anti-CCP Reagent Kit 200 Tests
Published
2018-12-04
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740151362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740151362003807401513623807401513620380740151362

GMDN Terms#

Term, Definition table
TermDefinition
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide (anti-CCP) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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
05055845400497Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAAXIS-SHIELD DIAGNOSTICS LIMITEDNHX2019-08-02
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
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