FDA.reportPublic FDA data

AccuDiag™

Primary DI
00894175000312
Brand
AccuDiag™
Company
Diagnostic Automation, Inc.
Model
DACD310-100
Catalog number
310-100
Device description
AccuDiag™CRP Latex Test KitC- Reactive Protein (CRP) latex slide test is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum.
Published
2021-08-26
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
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
00894175000312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894175000312008941750003128941750003120894175000312

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.

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
8185913030onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
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
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

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
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
10859035006016IMMUNEX CRP® ALERE NORTH AMERICA, LLCDCN2016-09-24
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