Home GUDID 00816057020010
ASI Sickle Cell Test
Primary DI 00816057020010
Brand ASI Sickle Cell Test
Company ARLINGTON SCIENTIFIC, INC.
Model NC-200025E
Catalog number NC-200025E
Device description Detection of the presence of Hgb-S for Export
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 GHM Test, Sickle Cell
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GHM Test, Sickle Cell Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816057020010 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 00816057020010 00816057020010 816057020010 0816057020010
GMDN Terms# Term, Definition table Term Definition Haemoglobin S (HbS) 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 determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, 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 20 Degrees Celsius 30 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 00860003629901 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00860003629918 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00860003629925 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00860003629932 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00860003629949 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00630414976341 Dade® Sickle-Sol Test Siemens Healthcare Diagnostics Products GmbH GHM 2016-09-24 00630414976365 Dade® Sickle-Sol Test Siemens Healthcare Diagnostics Products GmbH GHM 2016-09-24 00844509000884 Sickle-Chex STRECK, INC. GHM 2016-09-19 00844509000891 Sickle-Chex STRECK, INC. GHM 2016-09-19 00844509002024 SICKLEDEX STRECK, INC. GHM 2016-09-19 00844509002031 SICKLEDEX STRECK, INC. GHM 2016-09-19 00844509002048 SICKLEDEX STRECK, INC. GHM 2016-09-19 00845275000740 Thermo Scientific Pacific Hemostasis® Fisher Diagnostics GHM 2016-09-16 00845275000757 Thermo Scientific Pacific Hemostasis® Fisher Diagnostics GHM 2016-09-16 00845275000733 Thermo Scientific Pacific Hemostasis® Fisher Diagnostics GHM 2016-07-19 00816057020003 ASI Sickle Cell Test ARLINGTON SCIENTIFIC, INC. GHM 2016-07-08 00816057020027 ASI Sickle Cell Test ARLINGTON SCIENTIFIC, INC. GHM 2016-07-08 00816057020034 ASI Sickle Cell Test ARLINGTON SCIENTIFIC, INC. GHM 2016-07-08