Home GUDID 10810143620068 GenaCheck 12-Drug Rapid Self-Test Kit
Primary DI 10810143620068
Brand GenaCheck 12-Drug Rapid Self-Test Kit
Company Genabio Diagnostics Inc.
Model RA9-E01902
Published 2023-10-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
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 00810143620061 Primary GS1 0 10810143620068 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 00810143620061 00810143620061 810143620061 0810143620061 10810143620068 10810143620068
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.
Regulatory Flags# DUNS number 118586095 Device count 2 DM exempt false Premarket exempt true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810143620221 GenaCheck® Early Result Pregnancy Test N/A 2025-02-26 00810143620115 GenaCheck® Nitrile Powder Free Examination Glove N/A ZC8-E19700 2025-01-13 00810143620139 GenaCheck® Nitrile Powder Free Examination Glove N/A ZC8-E19800 2025-01-13 00810143620146 GenaCheck® Nitrile Powder Free Examination Glove N/A ZC8-E19900 2025-01-13 00810143620153 GenaCheck® Nitrile Powder Free Examination Glove N/A ZC8-E20100 2025-01-13 00860008954800 GenaCheck™ Fentanyl Urine Home-Use Test Cassette RA9-E02525 RA9-E02501 2024-06-14 00810143620122 GenaCheck® COVID-19 Rapid Self-Test 2T N/A 2026-01-21 00810143620382 GenaCheck® COVID-19 Rapid Self-Test 20T N/A 2026-01-21 00810143620399 GenaCheck® COVID-19 Rapid Self-Test 4T N/A 2026-01-21 00810143620344 GenaCheck® COVID-19/Flu A&B Rapid Self-Test RA9-E02402 2025-05-19 00810143620368 GenaCheck® COVID-19/Flu A&B Rapid Self-Test RA9-E02404 2025-05-19 00810143620214 GenaCheck® FSH At-Home Menopause Test N/A 2025-02-26 00810143620184 Genabio COVID-19 Rapid Self-Test Kit N/A 2025-01-13 00810143620191 GenaCheck®LH At-Home Ovulation Prediction Test N/A 2025-01-13 00810143620207 GenaCheck®PdG At-Home Ovulation Confirmation Test N/A 2025-01-13 00860008954817 GenaCheck®Fentanyl Urine Test Cassette N/A RA9-E02525 2025-01-13 00810143620009 GenaCheck Rapid Self-Test Kit For Urinary Tract Infections RA9-E01802 2023-10-06 00810143620047 GenaCheck Alcohol Rapid Self-Test Kit RA9-E01905 2023-10-06 00810143620054 GenaCheck 5-Drug Rapid Self-Test Kit RA9-E02105 2023-10-06 00810143620061 GenaCheck 12-Drug Rapid Self-Test Kit RA9-E01902 2023-10-06
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