Model: CMC1NJNF
DI: 05032384574230
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7f527232-8e98-4271-a0ed-1764e9c26339
Distribution Status:
In Commercial Distribution
DUNS Number:
298203498
Device Count:
10
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
05032384574230
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05032384594061
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 63869
Name: Multiple antibacterial susceptibility testing kit IVD
Definition:
A collection of reagents and other associated materials containing a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection), that may be impregnated on individual testing discs or in a strip format, intended to be used to determine the antibacterial susceptibility profile of a specific bacterial microorganism (excluding mycobateria), in a clinical specimen and/or culture isolate.
FDA Product Codes
JWY
Manual Antimicrobial Susceptibility Test Systems