Device
Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
Manufacturer
Alere Scarborough, Inc.
Alere Scarborough, Inc.
Model: 20002351
DI: 00811877012221
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cf0faeaa-575e-4597-b830-78d0b64b12e2
Distribution Status:
In Commercial Distribution
DUNS Number:
154148498
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
00811877012221
Type:
Primary
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