Home GUDID EABA10090110 BRT Verification Samples
Primary DI EABA10090110
Brand BRT Verification Samples
Company Bioresource Technology
Model 100-9011
Catalog number 100-9011
Device description BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.
Published 2021-04-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name OHQ Multi-Analyte Controls Unassayed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OHQ Multi-Analyte Controls Unassayed Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EABA10090111 Primary HIBCC 0 EABA10090110 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
Regulatory Flags# DUNS number 928908037 Device count 3 DM exempt false Premarket exempt true HCT/P false Kit false 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 EABA10090101 BRT Liquid Assayed Chemistry Control 100-9010 100-9010 2021-04-01 EABA10090111 BRT Verification Samples 100-9011 100-9011 2021-04-01 EABA10090201 BRT Liquid Assayed Chemistry Control with CRP 100-9020 100-9020 2021-04-01 EABA10090211 BRT Verification Samples with CRP 100-9021 100-9021 2021-04-01 EABA10090100 BRT Liquid Assayed Chemistry Control 100-9010 100-9010 2021-04-01 EABA10090200 BRT Liquid Assayed Chemistry Control with CRP 100-9020 100-9020 2021-04-01 EABA10090210 BRT Verification Samples with CRP 100-9021 100-9021 2021-04-01
Other Devices Sharing Product Codes#