BOND ORACLE HER2 IHC System TA9145

GUDID 05055331301291

Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue pr

LEICA BIOSYSTEMS NEWCASTLE LTD

C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistry
Primary Device ID05055331301291
NIH Device Record Keya7475889-95a1-4916-a866-cf51a7ff5642
Commercial Distribution StatusIn Commercial Distribution
Brand NameBOND ORACLE HER2 IHC System
Version Model NumberTA9145
Catalog NumberTA9145
Company DUNS397134693
Company NameLEICA BIOSYSTEMS NEWCASTLE LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 800 248 0123
Emailtech.support@Leicabiosystems.c

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055331301291 [Primary]

FDA Product Code

MVCSystem, Test, Her-2/Neu, Ihc

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-23

Devices Manufactured by LEICA BIOSYSTEMS NEWCASTLE LTD

05055331337504 - BOND-PRIME2024-06-19 For in vitro diagnostic use. ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and pol
05055331336323 - BOND2024-03-11 This reagent is for in vitro diagnostic use. LEF-1 (EPR2029Y) is intended to be used for the qualitative identification by light
05055331336330 - BOND2024-03-11 This reagent is for in vitro diagnostic use. H-Caldesmon (BSB-19) is intended to be used for the qualitative identification by l
05055331336354 - BOND2024-03-11 This reagent is for in vitro diagnostic use. Arginase-1 (EPR6672(B)) is intended to be used for the qualitative identification b
05055331336361 - BOND2024-03-11 This reagent is for in vitro diagnostic use. EpCAM (EPR20532-222) is intended to be used for the qualitative identification by l
05055331336378 - BOND2024-03-11 This reagent is for in vitro diagnostic use. Desmoglein 3 (EPR14101) is intended to be used for the qualitative identification b
05055331336804 - BOND2024-03-11 This reagent is for in vitro diagnostic use. IgG4 (HP6023) is intended to be used for the qualitative identification by light mi
05055331337009 - BOND2024-03-11 This reagent is for in vitro diagnostic use. GLUT1 (GLUT1/2475) is intended to be used for the qualitative identification by lig

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.