Model: ALI3154DSG25
DI: 00847627051622
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
90834dcc-4b44-4695-ae6d-dd0fbb0cc087
Distribution Status:
In Commercial Distribution
DUNS Number:
806617825
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:
00847627051622
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57543
Name: Multiple prostate cancer-associated marker IVD, antibody
Definition:
Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple markers potentially associated with prostate cancer in a clinical specimen. Examples of detectable markers include prostatic intraepithelial neoplasia markers (e.g., cytokeratin HMW), prostate specific antigen (PSA), alpha-methylacyl-CoA racemase (AMACR), and p63 tumour protein.
FDA Product Codes
NJT
Immunohistochemistry Reagents And Kits
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