Home GUDID 00816057020195 ASI SLE Slide Test
Primary DI 00816057020195
Brand ASI SLE Slide Test
Company ARLINGTON SCIENTIFIC, INC.
Model NC-350025
Catalog number NC-350025
Device description Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
Published 2016-07-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name DHC System, Test, Systemic Lupus Erythematosus
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DHC System, Test, Systemic Lupus Erythematosus Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816057020195 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816057020195 00816057020195 816057020195 0816057020195
GMDN Terms# Term, Definition table Term Definition Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple antibodies associated with systemic lupus erythematosus (SLE) in a clinical specimen.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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 DI Brand Model Catalog Published 00816057021666 ASI Evolution NC-2800-000 NC-2800-000 2023-12-19 00816057021673 ASI RPR Test for Syphilis for Use on the ASI Evolution NC-900480ABB NC-900480ABB 2023-12-19 00816057021680 ASI RPR Test for Syphilis for Use on the ASI Evolution NC-9004800ABB NC-9004800ABB 2023-12-19 00816057021697 ASI RPR Automated Control Set NC-905002.5A NC-905002.5A 2023-12-19 00816057021703 ASI RPR Automated Control Set NC-905005A NC905005A 2023-12-19 00816057021710 ASI Evolution RPR Titration Diluent NC-5300-905A NC-5300-905A 2023-12-19 00816057021796 ASI RPR Card Test for Syphilis NC-900100EX NC-900100EX 2023-12-19 00816057021802 ASI RPR Card Test for Syphilis NC-900500EX NC-900500EX 2023-12-19 00816057021826 ASI Color Staph Latex Test NC-285-050 NC-285-050 2023-12-19 00816057021833 ASI Color Staph Latex Test NC-285-050 NC-285-050 2023-12-19 00816057021840 ASI Color Staph Latex Test NC-285-300 NC-285-300 2023-12-19 00816057020409 ASI Rubella Test NC-600030 NC-600030 2016-07-08 00816057020416 ASI Rubella Test NC-600030E NC-600030E 2016-07-08 00816057020423 ASI Rubella Test NC-600100 NC-600100 2016-07-08 00816057020430 ASI Rubella Test NC-600100E NC-600100E 2016-07-08 00816057020447 ASI Rubella Test NC-600500 NC-600500 2016-07-08 00816057020454 ASI Rubella Test NC-600500E NC-600500E 2016-07-08 00816057020041 ASiManager-AT NC-2400-0BT NC-2400-0BT 2016-07-08 00816057020058 ASI Infinity Analyzer NC-2700-000 NC-2700-000 2016-07-08 00816057021628 ASI CRP Control Set NC-505001 NC-505001 2016-07-08
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850049545907 AccuDiag ™ Diagnostic Automation, Inc. DHC 2023-06-14 00813545026585 MeDiCa SCIMEDX CORPORATION DHC 2020-12-01 00813545026592 MeDiCa SCIMEDX CORPORATION DHC 2020-12-01 00813545026929 MeDiCa SCIMEDX CORPORATION DHC 2020-11-04 00813545026936 MeDiCa SCIMEDX CORPORATION DHC 2020-11-04 00813545026943 MeDiCa SCIMEDX CORPORATION DHC 2020-11-04 10722355001712 Detector Lex SLE Immunostics Company, Inc DHC 2016-09-21 10722355001729 Detector Lex SLE Immunostics Company, Inc DHC 2016-09-21 00847817018206 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018213 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018220 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018237 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018244 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018251 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018268 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018275 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00847817018282 Autoimmune EIA BIO-RAD LABORATORIES, INC. DHC 2016-09-12 00855360006120 Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION DHC 2016-07-14 00855360006137 Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION DHC 2016-07-14 00855360006212 REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit CORGENIX MEDICAL CORPORATION DHC 2016-07-14 00816057020201 ASI SLE Slide Test ARLINGTON SCIENTIFIC, INC. DHC 2016-07-08 00816057020218 ASI SLE Slide Test ARLINGTON SCIENTIFIC, INC. DHC 2016-07-08 00816057020225 ASI SLE Slide Test ARLINGTON SCIENTIFIC, INC. DHC 2016-07-08 00816057020232 ASI SLE Slide Test ARLINGTON SCIENTIFIC, INC. DHC 2016-07-08 00816057020249 ASI SLE Slide Test ARLINGTON SCIENTIFIC, INC. DHC 2016-07-08 00816057020256 ASI SLE Slide Test ARLINGTON SCIENTIFIC, INC. DHC 2016-07-08 00816057021604 ASI SLE Slide Test Control Set ARLINGTON SCIENTIFIC, INC. DHC 2016-07-08
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