SARS-CoV-2 (COVID-19) Antigen Lateral Flow Device Self-Test Device
JS Group are now able to supply the UK National Health Service, and other government Test & Trace services with the highest quality COVID-19 antigen lateral flow self-test device available anywhere on the market today. Our LFT self-test device performance exceeds all WHO specifications in terms of specificity and sensitivity. Demonstrated performance against medium and high viral load infections. Please download our brochure for key features and benefits below.
Our rapid point-of-care lateral-flow viral antigen tests provide high-specificity and sensitivity results in 10-15 minutes and compare very favourably to the laboratory -based RT-PCR swab test. Our antigen tests use a nasal swab sample.
Our KISSHEALTH test specifications exceed World Health Organisation (WHO) and UK Health Security Agency (UKHSA) requirements across all parameters, are easy to use and the results are simple to interpret with built-in quality controls to ensure accuracy of results. KISSHEALTH antigen self-test has DHSC Phase 3 approval and is registered with the MHRA. The DHSC approval can be viewed here:
Our rapid antigen test has been independently validated against the standard RT-PCR molecular test to ensure accuracy against false negatives. We have gone to extraordinary lengths to ensure that our supplier has regulator-inspected design and production facilities that comply with all ISO/EN standards, operate audited quality management systems, and that all products have the CE-mark and conformity to the latest European Medical Device Directives including IVDD regulations. This ensures that we comply with the United Kingdom MHRA requirements to place medical devices on the market for free sale. Our supplier uses the best methods of quality control, regulatory assurance and good manufacturing practice.
KISSHEALTH Self-Test Device Highlights
Test Pack Sizes
K602-1H (single pack)
K602-5H (5 pack)
K602-7H (7 pack)
K602-20H (20 pack)
Includes test cassette, sample swab, viral extraction buffer, full instructions for use & biohazard disposal bag. 18-months shelf-life.
Convenient
Our home Self-Test Devices offer results in under 15 min.
Reliable
Full UK Health Security Agency (DHSC) Phase 3 Validation by Porton Down.
Registered with the UK Medical and Healthcare Products Regulatory Agency (MHRA).
Certified
CE-Marked in full compliance with all applicable UK and EU Medical Device Regulations for IVD devices
Effective
Effective against all currently known variants including the latest Omicron (B.1. 1.529)
Highly accurate results with strong clinical and analytical performance data to support the efficacy
Well documented
Individual identification for each test with unique QR code
Cost-effective with discounts for high volumes
Well Established
Manufactured by a reputable long-standing In-Vitro Diagnostic Device manufacturer, not just one of the numerous opportunistic pop-up companies
In wide use in many countries in Europe and around the world
Government Approved
Manufacturer is listed on the Chinese FDA and Ministry of Foreign Affairs Whitelist
Manufacturing production capacity of up to 3 million tests per day
We are one of the only companies in the UK that can offer point-of-care self-tests for use at home from independent, longstanding in-vitro diagnostic medical manufactures who have a long and established presence in this market. We do not use “pop-up” manufacturers with no experience in making viral test systems that have been proven to be inaccurate and unreliable.
Our manufacturer can produce 3 million tests per day. We can guarantee a continuous supply of antigen and antibody test solutions as the world demand for high-quality devices increases. Our tests are already in use by many governments around in Europe and around the world.
Please contact us for further technical and price information on
+44 (0)1234 888955 or +44 (0)7774 930316 or at
info@js-group.global
UK Medical Device Registration Services United Kingdom Responsible Person (UKRP)
Since 1st January 2021, it is a legal requirement for all foreign medical device manufacturers to register their products with the Medicines and Healthcare Products Regulatory Agency (MHRA) using a UKRP before placing their products for sale on the United Kingdom market, even if they are originally CE-marked and currently on-sale.
JS Group provide a full range of professional regulatory services to medical device manufacturers and importers at very realistic costs.
Download our brochure below for more information on UKPR