Home GUDID 00722066006627 Rapid Response
Primary DI 00722066006627
Brand Rapid Response
Company BTNX Inc
Model D10.3.2-2FC1E
Device description Rapid Response 10 Panel Saliva Test Cup E/I Screening (D10.3.2-2FC1E)- THC40, COC20, OPI40, AMP50, MET50, BAR50, BZO10, MDMA50, MTD30, PPX50. For employment and insurance testing.
Published 2022-12-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PVI Test, Propoxyphene, Employment And Insurance Testing, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PVI Test, Propoxyphene, Employment And Insurance Testing, Exempt Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10722066006624 Primary GS1 0 00722066006627 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 10722066006624 10722066006624 00722066006627 00722066006627 722066006627 0722066006627
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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10722066006624 Rapid Response BTNX Inc PVI 2022-12-07 10722066006617 Rapid Response BTNX Inc PVI 2022-12-07