FDA Flowflex Home Test Kit Nasal Specimen Nasopharyngeal Test Kit
Nasopharyngeal test packing size:
product name | REF | format | kit size | carton size | carton size(mm) | weight | quantity per carton |
SARS | L031-118R* | cassette3.5mm | 25 | 600 | 445*400*410 | 12.2 | 600 |
cov-2 | L031-118P* | cassette3.5mm | 5 | 600 | 520*395*440 | 11.5 | 300 |
antigen | | cassette3.5mm | 1 | 300 | 565*390*365 | 11.5 | 300 |
self test | L031-118B5 | | | | | | |
Gov Lateral Flow Tests:
Qualitative detection of the nucleocapsid protein antigen 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 Antigen Home Test does not require serial testing.
• Anteriornasal swab specimens
• Results in 15 minutes
• 12 Months shelf life
• Store between 36 to 86° F
• Sample self-collection ages 14 and older
• Samplecollection by an adult inchildren ages 2 to 13
• Excellent performance when compared to an FDA authorized
molecular Cov 2 antigen test.
Clinical Performance:
The Flowflex Antigen Home Test was compared to an FDA authorized molecular Cov 2 antigen test.
The Flowflex Antigen Home Test correctly identified 93% of positive specimens and 100% of negative specimens. 