Home GUDID 00894354002236 MyCare Psychiatry
Primary DI 00894354002236
Brand MyCare Psychiatry
Company SALADAX BIOMEDICAL, INC.
Model CLZ-RGT
Catalog number CLZ-RGT
Device description Clozapine Assay Kit
Published 2020-05-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QKT Clozapine Test System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QKT Clozapine Test System Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00894354002236 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 00894354002236 00894354002236 894354002236 0894354002236
GMDN Terms# Term, Definition table Term Definition Clozapine IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of clozapine in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 144379539 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00894354002397 Beckman Coulter SALADAX BIOMEDICAL, INC. QKT 2022-06-15