FDA.reportPublic FDA data

IMMULITE® 2000 Systems CCP Anti-CCP IgG

Primary DI
00630414601991
Brand
IMMULITE® 2000 Systems CCP Anti-CCP IgG
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10718148
Catalog number
L2KPI2(D)
Device description
CCP IgG Ab - IMMULITE - RGT - 200 Tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K121576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121576000IMMULITE 2000 ANTI-CCP IGG ASSAYSiemens Healthcare Diagnostics, Inc.2013-04-04NHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414601991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414601991006304146019916304146019910630414601991

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 Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
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
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