Model: 50005827 version 2
DI: 07350136800344
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Antimicrobial Susceptibility Testing - Gram negative
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9958ad0d-fd6d-43c5-a45c-caa83d78b986
Distribution Status:
In Commercial Distribution
DUNS Number:
775813863
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07350136800344
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65229
Name: Antimicrobial susceptibility/resistance testing interpretive software IVD
Definition:
An in vitro diagnostic software program intended to be used for the interpretation of results of an in vitro diagnostic assay [e.g., minimum inhibitory concentration (MIC), mass spectrometry (MALDI-TOF)] performed on a microbial culture isolated from a clinical specimen, to determine the susceptibility, intermediate or resistance categorization of the microbial species. It is installed on an off-the-shelf computer or a web-based platform, and compares assay results (e.g., an acquired image, mass spectrum) to reference data to determine antimicrobial resistance (e.g., beta-lactamase, carbapenamase, and/or cephalosporinase activity). Results are used to guide patient treatment options.
FDA Product Codes
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation