FDA.reportPublic FDA data

IMMAGE

Primary DI
15099590203160
Brand
IMMAGE
Company
Beckman Coulter, Inc.
Model
A38656
Catalog number
A38656
Device description
IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071002000IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENTBeckman Coulter, Inc.2007-06-21NQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590203160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959020316015099590203160

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414611112Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics Inc.NQD2024-06-11
00630414305028Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics Inc.NQD2024-06-11
07613336121207Cardiac C-Reactive Protein (Latex) High SensitiveRoche Diagnostics GmbHNQD2020-03-05
00380740180331AlinityABBOTT LABORATORIESNQD2020-01-13
00380740181024AlinityABBOTT LABORATORIESNQD2020-01-13
00380740158491ARCHITECTABBOTT LABORATORIESNQD2018-12-28
00380740158507ARCHITECTABBOTT LABORATORIESNQD2018-12-28
00630414596174Atellica CH hsCRPSiemens Healthcare Diagnostics Inc.NQD2017-12-21
15099590010959AUBeckman Coulter, Inc.NQD2016-09-24
00842768006135Dimension Vista hsCRP Flex reagent cartridgeSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768007729CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768007736CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768016028Dimension CardioPhase high sensitivity CRP Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.NQD2016-09-24
00630414552699ADVIA Chemistry CardioPhase High Sensitivity C-Reactive ProteinSiemens Healthcare Diagnostics Inc.NQD2016-09-24
00630414953144IMMULITE® Systems CRP CONTROL C-Reactive ProteinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414953670IMMULITE®/IMMULITE® 1000 Systems CRP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414953687IMMULITE® 2000 Systems CRP CRP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414961200IMMULITE® 2000 Systems hsC High Sensitivity CRPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414963792IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
04015630912209Tinaquant Cardiac Creactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
04015630921508Cardiac CReactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
04015630928774Cardiac CReactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
10758750006885VITROSORTHO-CLINICAL DIAGNOSTICS, INC.NQD2016-08-26
15099590228682SynchronBeckman Coulter, Inc.NQD2016-08-24