MAGE-A4 IHC 1F9 pharmDx

GUDID 05700573007400

MAGE-A4 IHC 1F9 pharmDx

AGILENT TECHNOLOGIES, INC.

Melanoma-associated antigen (MAGE) IVD, kit, enzyme immunohistochemistry
Primary Device ID05700573007400
NIH Device Record Key9c30af27-07a0-4aea-92f2-df2c723166fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAGE-A4 IHC 1F9 pharmDx
Version Model NumberSK032
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 Kittrue
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
GS105700573007400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SBLImmunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-09
Device Publish Date2024-10-01

Devices Manufactured by AGILENT TECHNOLOGIES, INC.

05700573007400 - MAGE-A4 IHC 1F9 pharmDx2024-10-09MAGE-A4 IHC 1F9 pharmDx
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
05700571112311 - Dako2024-08-15 Dako Omnis Small Vial, 2 mL
05700571112328 - Dako2024-08-15 Dako Omnis Large Vial, 30 mL
05700574037420 - SureFISH 13q14.2 RB1 522kb P20 GR2024-06-17 SureFISH 13q14.2 RB1 522kb P20 GR
05700574007164 - 406FX-SI2023-04-04 Microplate Washer Dispenser
05700574034320 - BSTCK2WR-SI2023-04-04 Microplate Stacker
05700574034337 - BSTCK3WR-SI2023-04-04 Microplate Stacker

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