FDA.reportPublic FDA data

ASI CRP Slide Test

Primary DI
00816057020393
Brand
ASI CRP Slide Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-5001000
Catalog number
NC-5001000
Device description
Detection of C-Reactive Protein
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K821388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821388000SERO/TEX CRP TESTTexas Immunology, Inc.1982-07-02DCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020393008160570203938160570203930816057020393

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
801-489-8911info@arlingtonscientific.com

Regulatory Flags#

DUNS number
785966607
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
00816057021666ASI EvolutionNC-2800-000NC-2800-0002023-12-19
00816057021673ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-900480ABBNC-900480ABB2023-12-19
00816057021680ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-9004800ABBNC-9004800ABB2023-12-19
00816057021697ASI RPR Automated Control Set NC-905002.5ANC-905002.5A2023-12-19
00816057021703ASI RPR Automated Control Set NC-905005ANC905005A2023-12-19
00816057021710ASI Evolution RPR Titration DiluentNC-5300-905ANC-5300-905A2023-12-19
00816057021796ASI RPR Card Test for SyphilisNC-900100EXNC-900100EX2023-12-19
00816057021802ASI RPR Card Test for SyphilisNC-900500EXNC-900500EX2023-12-19
00816057021826ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
00816057021833ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
00816057021840ASI Color Staph Latex TestNC-285-300NC-285-3002023-12-19
00816057020409ASI Rubella TestNC-600030NC-6000302016-07-08
00816057020416ASI Rubella Test NC-600030ENC-600030E2016-07-08
00816057020423ASI Rubella TestNC-600100NC-6001002016-07-08
00816057020430ASI Rubella TestNC-600100ENC-600100E2016-07-08
00816057020447ASI Rubella TestNC-600500NC-6005002016-07-08
00816057020454ASI Rubella TestNC-600500ENC-600500E2016-07-08
00816057020041ASiManager-ATNC-2400-0BTNC-2400-0BT2016-07-08
00816057020058ASI Infinity AnalyzerNC-2700-000NC-2700-0002016-07-08
00816057021628ASI CRP Control SetNC-505001NC-5050012016-07-08

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
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