Home GUDID 10743816000464 Status DS™ 9 card
Primary DI 10743816000464
Brand Status DS™ 9 card
Company PRINCETON BIOMEDITECH CORPORATION
Model DOA-290-25-01
Catalog number DOA-290-25-01
Device description Status DS™ ME/O/C/TH/P//BZ/BA/TC/A card; 25 Test kit
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIS Enzyme Immunoassay, Barbiturate DJC Thin Layer Chromatography, Methamphetamine DJG Enzyme Immunoassay, Opiates DKZ Enzyme Immunoassay, Amphetamine JXM Enzyme Immunoassay, Benzodiazepine LCM Enzyme Immunoassay, Phencyclidine LDJ Enzyme Immunoassay, Cannabinoids MLK Thin Layer Chroomatography, Tricyclic Antidepressant Drugs
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 DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology 2 DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2 DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology 2 JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology 2 LCM Enzyme Immunoassay, Phencyclidine Unknown U LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology 2 MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10743816000464 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10743816000464 10743816000464
GMDN Terms# Term, Definition table Term Definition Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of a specific amphetamine in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 362917692 Device count 1 Kit 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 10743816001553 Status™ COVID-19/Flu BSP-511-25 BSP-511-25 2021-02-15 10743816001621 Status™ COVID-19 Antigen Rapid Test for Home Use BSP-512-01-00 BSP-512-01-00 2023-10-20 10743816001638 Status™ COVID-19 Antigen Rapid Test for Home Use BSP-512-02-00 BSP-512-02-00 2023-10-20 10743816001645 Status™ COVID-19 Antigen Rapid Test for Home Use BSP-512-25-00 BSP-512-025-00 2023-10-20 10743816000532 BioSign® hCG card BSP-121-35-00 BSP-121-35-00 2016-09-23 10743816000556 Status hCG card BSP-121-35-01 BSP-121-35-01 2016-09-23 10743816000563 Status hCG card BSP-121-12-00 BSP-121-12-00 2016-09-23 10743816000570 BioSign® hCG card BSP-121-35-03 BSP-121-35-03 2016-09-23 10743816000587 BioSign® hCG card BSP-121-10-01 BSP-121-10-01 2016-09-23 10743816000594 Status hCG card BSP-121-35-06 BSP-121-35-06 2016-09-23 10743816000600 BioSign® hCG card BSP-121-35-07 BSP-121-35-07 2016-09-23 10743816000617 BioSign® hCG card BSP-121-35-10 BSP-121-35-10 2016-09-23 10743816000624 Status hCG controls BSP-121C-00 BSP-121C-00 2016-09-23 10743816000631 Status™ hCG S/U card BSP-120S-35-01 BSP-120S-35-01 2016-09-23 10743816000648 Status™ hCG S/U card BSP-120S-12-00 BSP-120S-12-00 2016-09-23 10743816000655 BioSign® hCG S/U card BSP-120S-35-04 BSP-120S-35-04 2016-09-23 10743816000662 BioSign® hCG S/U card BSP-120S-10-01 BSP-120S-10-01 2016-09-23 10743816000679 BioSign® hCG S/U card BSP-120S-35-09 BSP-120S-35-09 2016-09-23 10743816000686 Status™ hCG S/U card BSP-120S-10-03 BSP-120S-10-03 2016-09-23 10743816000693 StatusFirst™ hCG S/U card BSP-122-35-02 BSP-122-35-02 2016-09-23
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