Home GUDID 00810173656719 Healgen
Primary DI 00810173656719
Brand Healgen
Company Healgen Scientific Limited Liability Company
Model HCDOAV-1145A3
Device description K243365 14 Panel Cup Type #22 with Clicker and 3AD: AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, PPX300, TCA1000, THC50 + (OXI/SG/pH)
Published 2026-07-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIS Enzyme Immunoassay, Barbiturate DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine JXM Enzyme Immunoassay, Benzodiazepine JXN Enzyme Immunoassay, Propoxyphene LAF Gas Chromatography, Methamphetamine LCM Enzyme Immunoassay, Phencyclidine LDJ Enzyme Immunoassay, Cannabinoids LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology 2 DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 DJR Enzyme Immunoassay, Methadone Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology 2 JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology 2 JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology 2 LAF Gas Chromatography, Methamphetamine Clinical Toxicology 2 LCM Enzyme Immunoassay, Phencyclidine Unknown U LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2 LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10810173656716 Package GS1 25 In Commercial Distribution 20810173656713 Package GS1 4 In Commercial Distribution 00810173656719 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 10810173656716 10810173656716 20810173656713 20810173656713 00810173656719 00810173656719 810173656719 0810173656719
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 031802328 Device count 1 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 00817405024247 iScreen™ Instant Technologies, Inc. LDJ 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. LCM 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. LAF 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. JXM 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. DJG 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. DIS 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. DIO 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. JXN 2026-08-01 00817405024247 iScreen™ Instant Technologies, Inc. LFG 2026-08-01 B07609700 LZI Fentanyl III Enzyme Immunoassay LIN-ZHI INTERNATIONAL, INC. DJG 2026-07-17 B07609710 LZI Fentanyl III Enzyme Immunoassay LIN-ZHI INTERNATIONAL, INC. DJG 2026-07-17 00841824104167 ECOII W.H.P.M. INC. DJR 2026-07-07 00841824104167 ECOII W.H.P.M. INC. LAF 2026-07-07 00841824104167 ECOII W.H.P.M. INC. DIO 2026-07-07 00841824104167 ECOII W.H.P.M. INC. DIS 2026-07-07 00841824104167 ECOII W.H.P.M. INC. DJG 2026-07-07 00841824104167 ECOII W.H.P.M. INC. JXM 2026-07-07 00841824104167 ECOII W.H.P.M. INC. DKZ 2026-07-07 00841824104167 ECOII W.H.P.M. INC. LCM 2026-07-07 00841824104167 ECOII W.H.P.M. INC. LDJ 2026-07-07 00810174471229 Prime Screen® WONDFO USA CO., LTD. LCM 2026-06-26 10850013035431 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DIO 2026-06-25 10850013035431 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DJG 2026-06-25 10850013035431 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DKZ 2026-06-25 10850013035448 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DKZ 2026-06-25 10850013035448 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DIO 2026-06-25 10850013035448 Identify Health Drug Screen Test Cup MEDICAL DISTRIBUTION GROUP INC DJG 2026-06-25 00810173656726 Healgen Healgen Scientific Limited Liability Company JXN 2026-06-03 00810173656726 Healgen Healgen Scientific Limited Liability Company DKZ 2026-06-03 00810173656726 Healgen Healgen Scientific Limited Liability Company LDJ 2026-06-03
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