Product Details
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.
Company Profile
Founded in 2011, Signo is a high-tech enterprise specializing in
the development, production and sales of in vitro diagnostic
reagents.
The company has established a strict quality management system and
passed ISO9001: 2015 and ISO13485: 2016 international quality
system certifications.
It has advanced international fully automatic production equipment,
and the workshop is designed in strict accordance with standards
and has reached 10,000-level purification standards. Signo has
strong biotechnology power, and currently has more than 60
independent intellectual property rights, including 2 invention
patents, and undertakes many provincial and municipal science and
technology innovation projects.The products are mainly related to
microorganisms / clinical reagents, medical equipment / robots,
biochemical diagnostic reagents and so on. Signo's corporate
purpose is to care for human health, develop a magnificent career
in medical technology, and achieve a successful life. Guided by the
ingenious product concept of pursuing perfection, the company is
committed to providing disposable medical microbial culture
media.The company continuously improves technology and develops new
products according to market needs, and makes every effort to meet
customer needs.