Home GUDID 00850000596610 ihcDirect® EpCAM Ab, 5mL
Primary DI 00850000596610
Brand ihcDirect® EpCAM Ab, 5mL
Company NOVODIAX, INC.
Model K32039-005
Catalog number K32039-005
Device description Clone R1007
Published 2020-09-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name NJT Immunohistochemistry Reagents And Kits
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NJT Immunohistochemistry Reagents And Kits Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850000596610 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 00850000596610 00850000596610 850000596610 0850000596610
GMDN Terms# Term, Definition table Term Definition Epithelial cell adhesion molecule (EpCAM) IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of epithelial cell adhesion molecule (EpCAM), also known as epithelial surface antigen (ESA) and epithelial glycoprotein 2 (EGP-2), in a clinical specimen.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 5 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 21 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 965326957 Device count 1 Premarket exempt 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 00850041202419 QSX-Enh-P HER2 (ASR) AP31063-004 AP31063-004 2023-03-20 00850036867753 Q-STAIN® QSX-Enh-P WT-1 QP32045-004 QP32045-004 2023-11-21 00850036867760 Q-STAIN® QSX-Enh-F WT-1 QF32045-004 QF32045-004 2023-11-21 00850036867777 Q-STAIN® QSX-Enh-P Gal-3 QP32025-004 QP32025-004 2023-11-21 00850036867784 Q-STAIN® QSX-Enh-F Gal-3 QF32025-004 QF32025-004 2023-11-21 00850036867791 Q-STAIN® QSX-Enh-P TROP2 QP32044-004 QP32044-004 2023-11-21 00850036867807 Q-STAIN® QSX-Enh-F TROP2 QF32044-004 QF32044-004 2023-11-21 00850041202365 Q-STAIN® QSX-Enh-F CgA QF32035-004 QF32035-004 2023-11-21 00850041202372 Q-STAIN® QSX-Enh-P CgA QP32035-004 QP32035-004 2023-11-21 00850036867449 Q-STAIN® QSX-Enh-F CD34 QF31046-004 QF31046-004 2023-03-20 00850036867555 Q-STAIN® QSX-Enh-P CD34 QP31046-004 QP31046-004 2023-03-20 00850041202389 ihc CD34 Ab (3mL) KF31046-003 F31046-R003 / KF31046-003 2023-03-20 00850041202396 ihc CD34 Ab (5mL) KF31046-005 F31046-R005 / KF31046-005 2023-03-20 00850041202426 QSX-Enh-P ER (ASR) AP32052-004 AP32052-004 2023-03-20 00850041202433 QSX-Enh-P PR (ASR) AP32053-004 AP32053-004 2023-03-20 00850036867159 Q-STAIN® X Autostainer IA01-001 IA01-001 2022-02-04 00850036867166 Q-STAIN® QSX-Enh-P GFAP QP32002-004 QP32002-004 2022-07-21 00850036867173 Q-STAIN® QSX-Enh-P CD20 QP32029-004 QP32029-004 2022-07-21 00850036867180 Q-STAIN® QSX-Enh-P Vimentin QP32021-004 QP32021-004 2022-07-21 00850036867234 Q-STAIN® QSX-Enh-F Ki67 QF32001-004 QF32001-004 2022-07-21
Other Devices Sharing Product Codes# 
novodiax.com