Model: R30163901
DI: 05056080500928
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6201cd56-c86c-4eb3-acfe-227dfa1d2880
Distribution Status:
In Commercial Distribution
DUNS Number:
232600853
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:
05056080500928
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 51600
Name: Multiple Shigella species culture isolate antigen IVD, kit, agglutination
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple species of Shigella bacteria isolated by culture from a clinical specimen, using an agglutination method.
FDA Product Codes
GNB
Antisera, All Types, Shigella Spp.