Home GUDID 00811727017734 Pointe Multi-Analyte E DAU Level 1 Control
Primary DI 00811727017734
Brand Pointe Multi-Analyte E DAU Level 1 Control
Company POINTE SCIENTIFIC, INC.
Model 60-MA1794-15
Catalog number 60-MA1794-15
Device description Pointe Multi-Analyte E DAU Level 1 Control 1 x 15 mL The Pointe Multi-Analyte Set E Controls are for use as controls in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urine on anumber of automated clinical chemistry analyzers.
Published 2020-09-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name DIF Drug Mixture Control Materials
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DIF Drug Mixture Control Materials Clinical Toxicology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811727017734 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 00811727017734 00811727017734 811727017734 0811727017734
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse 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 045623154 Device count 1 DM exempt false Premarket exempt true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811727015709 Pointe Alkaline Phosphatase on the BS480 14-A7516-225 14-A7516-225 2020-05-28 00811727015723 Pointe Amylase on BS480 Analyzer 14-A7564-120 14-A7564-120 2020-05-28 00811727015730 Pointe AST on the BS480 Analyzer 14-A7561-375 14-A7561-375 2020-05-28 00811727015754 Pointe Calcium Arsenazo for BS480 14-C7529-360 14-C7529-360 2020-05-28 00811727015778 Pointe Cholesterol on BS480 14-C7510-480 14-C7510-480 2020-05-28 00811727015792 Pointe Carbon Dioxide on the BS480 14-C7502-160 14-C7502-160 2020-05-28 00811727015839 Pointe GGT on BS480 14-G7571-200 14-G7571-200 2020-05-28 00811727015846 Pointe Glucose Hexokinase for BS480 14-G7517-480 14-G7517-480 2020-05-28 00811727015860 Pointe autoHDL for the BS480 14-H7545-300 14-H7545-400 2020-05-28 00811727015877 Pointe Homocysteine for BS480 14-H7575-144 14-H7575-144 2020-05-28 00811727015884 Pointe Total Iron for the BS480 14-HI904-350 14-HI904-350 2020-05-28 00811727015693 Pointe Albumin on BS480 Analyzer 14-A7502-480 14-A7502-480 2020-05-28 00811727018632 Pointe Scientific CK-MB C7563-30 C7563-30 2021-02-28 00811727018649 Pointe Scientific CK-MB C7563-90 C7563-90 2021-02-28 00811727014139 Pointe G6PD Reagent G7583-180 G7583-180 2021-01-30 00811727015594 Pointe Lipoprotein (a) Control Set L7597-CTL L7597-CTL 2021-01-30 00811727015679 Pointe G6PD Controls G7583-CTL G7583-CTL 2021-01-30 00811727015815 Pointe CRP Reagent 14-C7568-480 14-C7568-480 2021-01-30 00811727015891 Pointe Lactate Reagent 14-L7596-380 14-L7596-380 2021-01-30 00811727015907 Pointe Lactate Dehydrogenase Reagent 14-L7572-200 14-L7572-200 2021-01-30
Other Devices Sharing Product Codes# 
medtestdx.com