Home GUDID 10858945006499 AlereTM iScreen®
Primary DI 10858945006499
Brand AlereTM iScreen®
Company Instant Technologies, Inc.
Model IS5A
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10858945006499 Primary GS1 0 00858945006492 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10858945006499 10858945006499 00858945006492 00858945006492 858945006492 0858945006492
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
Regulatory Flags# DUNS number 019410187 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810173655927 Healgen Healgen Scientific Limited Liability Company DIO 2026-03-11 10810173656006 Healgen Healgen Scientific Limited Liability Company DIO 2026-03-11 10810173656013 Healgen Healgen Scientific Limited Liability Company DIO 2026-03-11 10810173655573 Healgen Healgen Scientific Limited Liability Company DIO 2026-01-30 10810173655733 Healgen Healgen Scientific Limited Liability Company DIO 2026-01-30 00810173654784 Healgen Healgen Scientific Limited Liability Company DIO 2026-01-08 10810173655092 Healgen Healgen Scientific Limited Liability Company DIO 2026-01-08 10810173654590 Healgen Healgen Scientific Limited Liability Company DIO 2025-12-19 10810173654606 Healgen Healgen Scientific Limited Liability Company DIO 2025-12-19 10810173654620 Healgen Healgen Scientific Limited Liability Company DIO 2025-12-19 00850013035755 Identify® Diagnostics Drug Test Cards MEDICAL DISTRIBUTION GROUP INC DIO 2025-12-04 00850013035854 Identify® Diagnostics Drug Test Cards MEDICAL DISTRIBUTION GROUP INC DIO 2025-12-04 00850721007679 Identify® Diagnostics Drug Test Cards MEDICAL DISTRIBUTION GROUP INC DIO 2025-09-11 10810124273832 CERTUM One Step Multi-Drug Screen Panel ALERE SAN DIEGO, INC. DIO 2024-12-17 10810124273849 CERTUM One Step Multi-Drug Screen Panel ALERE SAN DIEGO, INC. DIO 2024-12-17 10810124273856 CERTUM One Step Multi-Drug Screen Panel ALERE SAN DIEGO, INC. DIO 2024-12-17 10810124273863 CERTUM One Step Multi-Drug Screen Panel ALERE SAN DIEGO, INC. DIO 2024-12-17 10810124273870 CERTUM One Step Multi-Drug Screen Panel ALERE SAN DIEGO, INC. DIO 2024-12-17 10815845023148 SureStep™ Urine Test Drug Screen Strip ALERE SAN DIEGO, INC. DIO 2024-12-17 00850013036004 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DIO 2024-11-20 06972412618569 Lyher Hangzhou Laihe Biotech Co.,Ltd. DIO 2024-11-12 10810124272972 CERTUM One Step Multi-Line Drug Screen EZ Split ALERE SAN DIEGO, INC. DIO 2024-10-10 10810124273795 CERTUM One Step Multi-Line Drug Screen EZ Split ALERE SAN DIEGO, INC. DIO 2024-10-10 10810124273801 CERTUM One Step Multi-Line Drug Screen EZ Split ALERE SAN DIEGO, INC. DIO 2024-10-10 10810124273818 CERTUM One Step Multi-Line Drug Screen EZ Split ALERE SAN DIEGO, INC. DIO 2024-10-10 10810124273825 CERTUM One Step Multi-Line Drug Screen EZ Split ALERE SAN DIEGO, INC. DIO 2024-10-10 10810124274518 CERTUM One Step Multi-Line Drug Screen EZ Split ALERE SAN DIEGO, INC. DIO 2024-10-10 10810124273146 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup ALERE SAN DIEGO, INC. DIO 2024-09-17 10810124273566 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup ALERE SAN DIEGO, INC. DIO 2024-09-17 10810124273573 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup ALERE SAN DIEGO, INC. DIO 2024-09-17
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