Device
FLEX Monoclonal Mouse Anti-Human Melan-A, Clone A103, Ready-to-Use (Dako Omnis)
Manufacturer
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model: GA633 DI: 05700572033028 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-15 Current Version: 2026-05-25
Description
FLEX Monoclonal Mouse Anti-Human Melan-A, Clone A103, Ready-to-Use (Dako Omnis)
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5da669c3-4215-470a-9765-ffbe425b98ba
Distribution Status: In Commercial Distribution
DUNS Number: 894671143
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 05700572033028
Type: Primary
Issuing Agency: GS1
GMDN
Code: 57393
Name: Melan-A/MART-1 peptide IVD, antibody
Definition:
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of Melan-A/MART-1 peptide in a clinical specimen.
FDA Product Codes
NJT
IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
Device Sizes
Device Size - Size - @attributes - Unit: Milliliter
Device Size - Size - @attributes - Value: 12
Device Size - Size Type: Total Volume
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: 2
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 8
Storage Handling - Storage Handling Type: Storage Environment Temperature