Home GUDID 10763924823533 ACCUTEST Drug Test Cup 13-Panel CLIA-Waived
Primary DI 10763924823533
Brand ACCUTEST Drug Test Cup 13-Panel CLIA-Waived
Company JANT PHARMACAL CORPORATION
Model DS823
Device description ACCUTEST Drug Test Cup 13-Panel CLIA-WaivedAMP 1000, BAR 300, BZO 300, BUP 10, COC 300, MDMA 500, MAD 300, MET 1000, OPI 300, OXY 100, PCP 25, TCA 1000, THC 50
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIS Enzyme Immunoassay, Barbiturate DJC Thin Layer Chromatography, Methamphetamine DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine JXM Enzyme Immunoassay, Benzodiazepine LCM Enzyme Immunoassay, Phencyclidine LDJ Enzyme Immunoassay, Cannabinoids LFH U.V. Spectrometry, 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 DJC Thin Layer Chromatography, Methamphetamine 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 LCM Enzyme Immunoassay, Phencyclidine Unknown U LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2 LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10763924823533 Primary GS1 0 00763924822539 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 10763924823533 10763924823533 00763924822539 00763924822539 763924822539 0763924822539
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 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. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 797393659 Device count 25 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 10763924750044 Accutest H. Pylori Urease Rapid Test ID750 2026-04-21 10763924601568 ACCUTEST Uriscreen Rapid Screen for UTI. Test ID601 2016-09-24 00763924540105 LipidPlus® Glucose Test Strips MD540 2017-02-16 10763924532107 LipidPlus® Total Cholesterol Test Strips MD532 2017-02-16 10763924550507 LipidPlus® Meter MD550 2017-02-16 10763924851109 Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived) PF851 2016-09-20 10763924853202 Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived) PF853 2016-09-20 10763924864208 Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) PF864 2016-09-20 10763924320919 Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS320 2016-09-20 10763924095213 Accutest Breath Alcohol Detector DS95AC220 2016-09-24 10763924097224 Accustrip Saliva Alcohol Test DS97AC125 2016-09-24 10763924210142 Accutest UA702A 2016-09-24 10763924410146 Accutest UA704A 2016-09-24 10763924710147 Accutest UA710A 2016-09-24 10763924850508 Accustrip Urine Reagent Strip Reader UA850 2016-09-24 10763924870100 Accustrip 10-Parameter Urine Reagent Strip UA870 00763924870103 2016-09-24 10763924319913 Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS319 2016-09-20 20763924897104 Accustrip URS Strips + Reader UA897 2016-09-24 10763924309914 Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS309 2016-09-20 10763924310910 Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS310 2016-09-20
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