FDA.reportPublic FDA data

IMMUNEX CRP®

Primary DI
10859035006016
Brand
IMMUNEX CRP®
Company
ALERE NORTH AMERICA, LLC
Model
71S2
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DCNSystem, Test, C-Reactive Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DCNSystem, Test, C-Reactive ProteinImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859035006016PrimaryGS10
00859035006019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085903500601610859035006016
00859035006019008590350060198590350060190859035006019

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].

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
1-877-441-7440ts.scr@alere.com

Regulatory Flags#

DUNS number
826027364
Device count
100
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859035006023DENCOCCULT™ IIIL103E2016-09-24
10859035006238Acceava® Mono Cassette924072016-09-24
10859035006214Wampole ColorCard® ASO 470502018-09-24
10859035006221Wampole ColorCard® Streptozyme® 460502018-09-24
10859035006009RHEUMATEX®34S22016-09-24
10859035006030IMPACT RPR™ TEST KIT (50 TESTS)60C1 2016-09-24
10859035006047IMPACT RPR™ TEST KIT (150 TESTS)60C22016-09-24
10859035006054IMPACT RPR™ TEST KIT (500 TESTS)60C32016-09-24
10859035006061IMPACT RPR™ TEST KIT (5000 TESTS)60C42016-09-24
10859035006078IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS)60C62016-09-24
10859035006085IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML61C02016-09-24
10859035006092IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML61C12016-09-24
10859035006108IMPACT RPR™ DRY CONTROL CARDS 10 EA61C22016-09-24
10859035006115IMPACT RPR™ LIQUID CONTROL 3 X 1 ML61C32016-09-24
10859035006122IMPACT RPR™ PIPETS/STIRRERS 500 EA61C42016-09-24
10859035006139IMPACT RPR™ 10 WELL TEST CARDS 300 EA61C52016-09-24
10859035006146IMPACT RPR™ 30 WELL TEST CARDS 100 EA61C72016-09-24
10859035006153IMPACT RPR™ NEEDLE/SHEATH 10 EA61C82016-09-24
10859035006160IMPACT RPR™ DISPENSING BOTTLES 10 EA61C92016-09-24
10859035006177IMPACT RPR™ PIPETS/STIRRERS 250 EA62C42016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414610887Atellica CH Revised C-Reactive Protein (RCRP)Siemens Healthcare Diagnostics Inc.DCN2024-02-02
00630414305127Atellica CH Revised C-Reactive Protein (RCRP)Siemens Healthcare Diagnostics Inc.DCN2024-02-02
00895160002694Nano-Check TM CRP plus TestNANO-DITECH CORPORATIONDCN2022-03-15
10895160002691Nano-Check TM CRP plus TestNANO-DITECH CORPORATIONDCN2022-03-15
00894175000312AccuDiag™Diagnostic Automation, Inc.DCN2021-08-26
00895160002670Fluoro-CheckTM CRP Test NANO-DITECH CORPORATIONDCN2020-09-22
10895160002677Fluoro-CheckTM CRP Test NANO-DITECH CORPORATIONDCN2020-09-22
07613336121191Tina-quant C-Reactive Protein IVRoche Diagnostics GmbHDCN2020-06-16
04015630946839Tina-quant CReactive Protein IVRoche Diagnostics GmbHDCN2020-05-13
04015630946846Tina-quant CReactive Protein IVRoche Diagnostics GmbHDCN2020-05-13
04015630946853Tina-quant CReactive Protein IVRoche Diagnostics GmbHDCN2020-05-13
07613336121184C-Reactive Protein Gen.3Roche Diagnostics GmbHDCN2020-03-05
05051700020152Optilite High Sensitivity C-Reactive Protein KitTHE BINDING SITE GROUP LIMITEDDCN2019-03-04
05051700018449Optilite C-Reactive Protein ReagentTHE BINDING SITE GROUP LIMITEDDCN2018-05-31
05051700020084Optilite C-Reactive Protein CalibratorTHE BINDING SITE GROUP LIMITEDDCN2018-05-31
05051700020091Optilite C-Reactive Protein ControlsTHE BINDING SITE GROUP LIMITEDDCN2018-05-31
00630414596198Atellica CH CRP_2Siemens Healthcare Diagnostics Inc.DCN2017-12-27
00006136471271Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2017-10-27
00006136471288Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2017-10-27
08806133010099ichroma ReaderBoditech Med Inc.DCN2017-10-26
05051700018456C-Reactive Protein Kit for SPAPLUSTHE BINDING SITE GROUP LIMITEDDCN2017-09-27
08806679001520ichroma™ CRPBoditech Med Inc.DCN2016-12-20
15099590010447AUBeckman Coulter, Inc.DCN2016-09-24
00842768006081Dimension Vista® C-Reactive Protein Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768011078RapiTex® CRPSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768011085RapiTex® CRPSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768012778RapiTex® CRPSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768014130Dimension® Flex® reagent cartridge RCRPSiemens Healthcare Diagnostics Inc.DCN2016-09-24
00630414552118ADVIA® Chemistry CRP_2 ReagentsSiemens Healthcare Diagnostics Inc.DCN2016-09-24
00613647001271Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2016-09-24