Home GUDID 10763924309914 Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Primary DI 10763924309914
Brand Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Company JANT PHARMACAL CORPORATION
Model DS309
Device description Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Published 2016-09-20
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 LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10763924309914 Primary GS1 0 00763924309917 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 10763924309914 10763924309914 00763924309917 00763924309917 763924309917 0763924309917
GMDN Terms# Term, Definition table Term Definition Tricyclic antidepressant 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 tricyclic antidepressant drugs 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.
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 10763924310910 Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS310 2016-09-20 10763924311917 Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS311 2016-09-20
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