Model: CAD-B13
DI: 06972077026327
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
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:
b55d9086-8e99-43c1-a911-a759915327ce
Distribution Status:
In Commercial Distribution
DUNS Number:
530563253
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06972077026327
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 50954
Name: Francisella tularensis antigen IVD, kit, rapid ICT, clinical
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Francisella tularensis in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with Francisella tularensis bacteria associated with tularaemia. It is not intended to be used for self-testing.
FDA Product Codes
KNN
Components, Wheelchair