Model: ICR-3000
DI: 00850078377098
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-01-02
Current Version: 2026-05-12
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
3
Record Key:
4d9286a9-3344-46a9-93f7-e0e19a1311b6
Distribution Status:
In Commercial Distribution
DUNS Number:
054953337
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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
Item #1 - Device ID:
10850078377095
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850078377098
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850078377098
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
20850078377092
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
48
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10850078377095
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 66040
Name: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
FDA Product Codes
SCA
Multi-Analyte Respiratory Virus Antigen Detection Test
Premarket Submissions
Submission Number:
K251085
Supplement Number:
000