Home GUDID 00850045519018 HER2/ER/PR IHControls®
Primary DI 00850045519018
Brand HER2/ER/PR IHControls®
Company Boston Cell Standards Inc
Model Level M
Catalog number BRL2U04
Device description HER2/ER/PR IHControls® - Level M are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.
Published 2023-11-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name NJW Control Material, Her-2/Neu, Immunohistochemistry
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NJW Control Material, Her-2/Neu, Immunohistochemistry Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850045519018 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 00850045519018 00850045519018 850045519018 0850045519018
Regulatory Flags# DUNS number 126775860 Device count 1 Lot or batch true Expiration date on label true Donation ID number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850045519001 HER2/ER/PR IHControls® Level H BRLS11 2023-11-14 00850045519025 HER2/ER/PR IHControls® Level L BRL2W08 2023-11-14
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850045519001 HER2/ER/PR IHControls® Boston Cell Standards Inc NJW 2023-11-14 00850045519025 HER2/ER/PR IHControls® Boston Cell Standards Inc NJW 2023-11-14