MSH2 IHC pharmDx (Dako Omnis)

GUDID 05700575005220

MSH2 IHC pharmDx (Dako Omnis)

AGILENT TECHNOLOGIES, INC.

MSH2 antigen IVD, antibody
Primary Device ID05700575005220
NIH Device Record Key2ec556eb-8a78-4fde-9367-e9755b528803
Commercial Distribution StatusIn Commercial Distribution
Brand NameMSH2 IHC pharmDx (Dako Omnis)
Version Model NumberGE085
Company DUNS084963177
Company NameAGILENT TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com
Phone+1-800-227-9770
EmailGlobal.RA@agilent.com

Device Dimensions

Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105700575005220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QNHImmunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-04
Device Publish Date2025-08-27

Devices Manufactured by AGILENT TECHNOLOGIES, INC.

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05700575005220 - MSH2 IHC pharmDx (Dako Omnis)2025-09-04 MSH2 IHC pharmDx (Dako Omnis)
05700575005237 - MSH6 IHC pharmDx (Dako Omnis)2025-09-04 MSH6 IHC pharmDx (Dako Omnis)
05700575005244 - PMS2 IHC pharmDx (Dako Omnis)2025-09-04 PMS2 IHC pharmDx (Dako Omnis)
05700575005251 - MMR Negative Control Reagent, Mouse (Dako Omnis)2025-09-04 MMR Negative Control Reagent, Mouse (Dako Omnis)
05700575005268 - MMR Negative Control Reagent, Rabbit (Dako Omnis)2025-09-04 MMR Negative Control Reagent, Rabbit (Dako Omnis)
05700573007400 - MAGE-A4 IHC 1F9 pharmDx2024-10-09 MAGE-A4 IHC 1F9 pharmDx
05700571112342 - Dako2024-08-15 Dako Omnis Vial with Mixing Ball, 2 mL

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