Acon Flowflex Sars-Cov-2 Antigen Rapid Test Kit

SARS-CoV-2 Rapid Antigen Test kit
Colloidal Gold Method Medical
Simple Rapid
Convenient
Sensitivity : 98.4%
Specificity : 98.1%
Test Time : 10-15min

For in vitro qualitative detect of Covid-19 antigen in nasal(NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of the symptoms. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.

1.Easy to collect samples simple operation without professional equipment.
2.The test results are available in 15 minutes, and the test results are clearly visible. 3.Convenient transportation and low price, higher accuracy.
4.Suitable for large-scale rapid screening.

Shelf life: 24 Months
Test Result time: 10 Mins
Packing: 25 Pieces per Box

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FlowFlex Sars-CoV-2 Antigen Rapid Test Self Test - Single Pack
The Flowflex SARS-CoV-2 Antigen Rapid Lateral FlowTest is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of an active COVID-19 infection by their healthcare provider within the first seven days of the onset of symptoms.

Supplied in a single pack
Cassette Format
Detects the nucleocapsid protein antigen from SARS-CoV-2
Nasal Specimen sample. Anterior Nares Only Test (2-4cm inside the nostril)
Results in 15 minutes
CE Marked for Self Test
Used by NHS track and trace as home test
Unique ID QR code number on each cassette
Pack Contents

1 x Test Cassette with QR code and unique ID number
1 x Extraction Buffer Tube
1 x Disposable Swab
1 x Waste Bag
1 x Package Insert
Features:

Fully Home Use Approved
FDA Approved
Validation from Public Health England Porton Down.
Full Home Test Approval Granted in the UK & EU
Registered with MHRA and CE Marked.
Used and trusted by companies around the world including all UK airports and the NHS.

1. Nasopharynx swab specimen, non-invasive
2. Very simple to use
3. Convenient, no devices required
4. Rapid, results within 20 minutes
5. Cost-efficient
6:Listed on German BfArm ,got approval by PEI
Clinical report from local CDC

Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.

Sensitivity: 95.06% Specificity: 99.62%

Content of each kit: Test card (innovative and unique system), detailed instructions for use, sterile disposable swab, reactive solution for sample treatment, illustrative manual for use and operation.

General characteristics: CE self-diagnostic certification, holographic security label with individual code for authenticity verification, non-invasive, easy to use, no prescription required, rapid results in less than 15 minutes, high precision.

Sale restrictions: Exclusive sale to pharmacies, authorized companies, pharmaceutical distribution, socio-sanitary establishments, health establishments, occupational risk prevention, public organizations and health professionals.

Restricted sale to individuals. Sale subject to the provisions of Royal Decree 588/2021, of July 20, which modifies Royal Decree 1662/2000, of September 29, on medical devices for "in vitro" diagnosis, in order to regulate the sale to the public and the advertising of covid-19 self-diagnosis products. Sale subject in relation to tax matters to the provisions of Royal Legislative Decree 35/2020, of December 22, seventh final provision. Applicable tax rate of Value Added Tax to deliveries, imports and intra-community acquisitions of certain goods and provision of services necessary to combat the effects of SARS-CoV-2 as well as for the purposes of the special regime of the equivalence surcharge .

BOSON RAPID SARS CoV-2 Antigen Test Card (Self Test) Manufactured by Xiamen Boson Biotech Co., Ltd.

DHSC - UK Approved - 3rd Phase Approved.
NASAL TEST
CE & ISO Approved
Full Home Test - Self Test Approval for UK and Europe
Test Result in 15 Minutes.
Sensitivity 97.70%
Specificity 99.84%
Accuracy 98.97%

Layperson study statistics
99.84% of non-professionals carried out the test without requiring assistance
99.82% of different types of results were interpreted correctly
Each Test have Unique Identifier Number - Easy to track
Approved By - UK, Germany, France, Spain, Netherlands, Greece, Belgium, Italy, Portugal.

1 Test / Kit
Catalog No.: 1N40C5-2
Kit Components:
1 Rapid SARS-CoV-2
Antigen Test Card (sealed
foil pouch)
1 sterilized swab
1 extraction tube
1 sample extraction buffer
IFU
Tube holder on back of box

Box / Carton Specifications :
1 Test / Kit
Box size - 190*60*15 mm
Carton size - 42*42*33 cm
Carton gross weight - 9.9 kg
250 tests (boxes) / carton

Euro 1.12

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