Home GUDID 00851000007069 Ten Panel PreScreen Plus Cup (CLIA Waived) With Alcohol
Primary DI 00851000007069
Brand Ten Panel PreScreen Plus Cup (CLIA Waived) With Alcohol
Company MERGERS MARKETING, INC.
Model PSC-DOA-4104A
Device description Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP BAR BZO COC MET MTD OPI OXY PCP THC With Alcohol
Published 2016-08-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIS Enzyme Immunoassay, Barbiturate DJG Enzyme Immunoassay, Opiates DJR Enzyme Immunoassay, Methadone DKZ Enzyme Immunoassay, Amphetamine JXM Enzyme Immunoassay, Benzodiazepine LAF Gas Chromatography, Methamphetamine LCM Enzyme Immunoassay, Phencyclidine LDJ Enzyme Immunoassay, Cannabinoids
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology 2 DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 DJR Enzyme Immunoassay, Methadone Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology 2 JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology 2 LAF Gas Chromatography, Methamphetamine Clinical Toxicology 2 LCM Enzyme Immunoassay, Phencyclidine Unknown U LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851000007076 Package GS1 25 In Commercial Distribution 10851000007073 Package GS1 4 In Commercial Distribution 00851000007069 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00851000007076 00851000007076 851000007076 0851000007076 10851000007073 10851000007073 00851000007069 00851000007069 851000007069 0851000007069
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 065602744 Device count 1 Premarket exempt 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 00850557007089 Twelve Panel PreScreen Plus Dip Card (CLIA Waived) PS-DOA-1124 2016-07-26 00850557007126 Five Panel PreScreen Plus Dip Card (CLIA Waived) PS-DOA-1554 2016-07-26 00850557007225 Ten Panel PreScreen Plus Dip Card (CLIA Waived) PS-DOA-3104 2016-07-26 00850557007263 Ten Panel PreScreen Plus Dip Card (CLIA Waived) PS-DOA-4104 2016-07-26 00850557007287 Six Panel PreScreen Plus Dip Card (CLIA Waived) PS-DOA-564 2016-07-26 00850557007409 Single Panel Pre Screen Plus Dip Card PS-THC-114 2016-07-26 00850557007485 Six Panel PreScreen Plus Cup With Adulterants (CLIA Waived) PSC-DOA-264AD 2016-07-25 00850557007829 Five Panel Clear Scan Drug Test Cup CSC-254 2016-07-25 00850557007843 Five Panel Clear Scan Drug Test Cup With Adulterants CSC-254AD 2016-07-25 00850557007867 Five Panel Clear Scan Drug Test Cup CSC-654 2016-07-25 00850557007980 Thirteen Panel Clear Scan Drug Test Cup CSC-2135 2016-07-25 00851000007007 Thirteen Panel Clear Scan Drug Test Cup With Adulterants CSC-2135 AD 2016-07-25 00851000007021 Twelve Panel Clear Scan Drug Test Cup With Adulterants CSC-6125AD 2016-08-31 00851000007045 Five Panel PreScreen Plus Cup (CLIA Waived) With Alcohol PSC-DOA-254A 2016-08-31 00851000007083 Single Panel Pre Screen Plus Dip Card PS-ETG 2016-08-31 00851000007106 Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) PSC-DOA-7125AD 2016-09-26 00851000007137 Five Panel PreScreen Plus Cup (CLIA Waived) PSC-DOA-154 2016-09-27 00851000007151 Six Panel PreScreen Plus Dip Card (CLIA Waived) PS-DOA-164 2016-11-08 00851000007168 Five Panel PreScreen Plus Mini Cup (CLIA Waived) PSC-DOA-254M 2016-12-07 00851000007175 Ten Panel PreScreen Plus Mini Cup (CLIA Waived) PSC-DOA-4104M 2016-12-07
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