Model: 1P31-27
Catalog: 01P3127
DI: 00380740193645
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
ARCHITECT iGentamicin Reagent Kit
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
543f1c06-d8bd-45be-8758-bcc377ff23fa
Distribution Status:
In Commercial Distribution
DUNS Number:
315786293
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
00380740193645
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61017
Name: Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Definition:
A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin in a clinical specimen, using a chemiluminescent immunoassay method.
FDA Product Codes
LCD
ENZYME IMMUNOASSAY, GENTAMICIN
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