Home GUDID 00816057020294 ASI Color Mono II Test
Primary DI 00816057020294
Brand ASI Color Mono II Test
Company ARLINGTON SCIENTIFIC, INC.
Model NC-450050E
Catalog number NC-450050E
Device description Detection of heterophil antibodies associated with infectious mononucleosis, 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 KTN System, Test, Infectious Mononucleosis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KTN System, Test, Infectious Mononucleosis Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816057020294 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 00816057020294 00816057020294 816057020294 0816057020294
GMDN Terms# Term, Definition table Term Definition Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.
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
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