Home GUDID 00722066007945 Rapid Response
Primary DI 00722066007945
Brand Rapid Response
Company BTNX Inc
Model D10.32-1VF
Device description 10 Panel One Step DOA cup - (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
Published 2024-04-01
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 NFY Test, Cocaine And Cocaine Metabolites, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10722066007942 Primary GS1 0 00722066007945 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 10722066007942 10722066007942 00722066007945 00722066007945 722066007945 0722066007945
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 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500200 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500217 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500224 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500231 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500248 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500255 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500262 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500279 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500286 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500293 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500309 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500316 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500323 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500330 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500347 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500354 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500361 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500378 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500385 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500392 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500408 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500415 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500422 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500439 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500446 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500453 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500460 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11