Home GUDID 10722066019013 Rapid Response
Primary DI 10722066019013
Brand Rapid Response
Company BTNX Inc
Model D10.32-1VF
Device description D10.32-1VF - COC300 MET1000 AMP1000 MOR2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
Published 2026-10-08
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 NFV Test, Benzodiazepine, Over The Counter NFW Test, Cannabinoid, Over The Counter NFY Test, Cocaine And Cocaine Metabolites, Over The Counter NGG Test, Methamphetamine, Over The Counter NGL Test, Opiates, Over The Counter NGM Test, Phencyclidine (Pcp), Over The Counter PTG Test, Methadone, Over The Counter PTH Test, Barbiturate, Over The Counter QAW Test, Tricyclic Antidepressants, Over The Counter QBF Test, Propoxyphene, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology 2 NFW Test, Cannabinoid, Over The Counter Clinical Toxicology 2 NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology 2 NGG Test, Methamphetamine, Over The Counter Clinical Toxicology 2 NGL Test, Opiates, Over The Counter Clinical Toxicology 2 NGM Test, Phencyclidine (Pcp), Over The Counter Unknown U PTG Test, Methadone, Over The Counter Clinical Toxicology 2 PTH Test, Barbiturate, Over The Counter Clinical Toxicology 2 QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology 2 QBF Test, Propoxyphene, Over The Counter Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20722066019010 Package GS1 100 In Commercial Distribution 10722066019013 Primary GS1 0 00722066019016 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 20722066019010 20722066019010 10722066019013 10722066019013 00722066019016 00722066019016 722066019016 0722066019016
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 251005005 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit true 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#