Item Brochure

aconlabs.com
PN: 2210033702 • Date 10/2021
© 2021 ACON Laboratories, Inc.
Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of
symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is authorized for non-prescription home
use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples
directly from individuals aged 2 years or older. The Flowflex COVID-19 Antigen Home Test does not require serial testing.
• Anterior nasal swab specimens
• Results in 15 minutes
• 12 Months shelf life
• Store between 36 to 86° F
Ordering Information
Flowflex COVID-19 Antigen Home Test
Materials Provided
Clinical Performance
Test Procedure and Interpretation
Catalog No.
L031-118B5
Product Name
Flowflex COVID - 19 antigen Home Test
Format
Cassette
Specimen
Nasal swabs
Package
1 Test/Kit
• Test Cassette(s)
• Package Insert
• Extraction Buffer Tube(s)
• Nasal Swab(s)
Invalid
Positive
Negative
The Flowflex COVID-19 Antigen Home Test was compared to an FDA authorized molecular SARS-CoV-2 test. The Flowflex COVID-19 Antigen Home Test
correctly identified 93% of positive specimens and 100% of negative specimens.
ACON Laboratories, Inc.
Oberlin Drive, # 340
San Diego, CA 92121, USA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
• Sample self-collection ages 14 and older
• Sample collection by an adult in children ages 2 to 13
• Excellent performance when compared to an FDA authorized
molecular SARS-CoV-2 test.
• This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.
• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs
for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated, or authorization is revoked sooner.
• For more information on EUAs please visit: https://www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency-use-
authorization
• For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
• For detailed instructions, please visit: www.aconlabs.com
L031-125M5
L031-125N5
Flowflex COVID - 19 antigen Home Test
Flowflex COVID - 19 antigen Home Test
Cassette
Cassette
Nasal Swabs
Nasal swabs
2 Tests/Kit
5 Tests/Kit
30 sec.
5 X
• External Tube Holder - Package of 25 tests
L031-125P5
Flowflex COVID - 19 antigen Home Test Cassette Nasal Swabs 25 Tests/Kit