LEPU MEDICAL - COVID-19 Rapid Test New Coronavirus Self Rapid Antigen Test Kit [For Omicron & Delta]-CE Cert – 1 Test/box
This product has been approved by the "Hong Kong Consumer Council" as a European Union (EU) series list
International certifications recognized by the HK government for this product include:
-CE EU certification - Directive 98/79/EC
-EU DoC-IVDD 98/97/EC
-Manufacturer compliant with EU EN ISO 13485
-Clinical research reports in Germany
-15-minute quick test for viruses, including Delta, Omicron variants
-Sample collection using a nasopharyngeal swab
-Ct value ≤25 Diagnostic sensitivity 97.0% /95%CI 84.7-99.5%
-Ct value ≤30 Diagnostic sensitivity 96.2% /95%CI 88.3-98.7%
-Ct value ≤36 Diagnostic sensitivity 95.9% /95%CI 90.8- 98.2%
*The above data is based on German clinical research results
-You can complete the new virus test in simple steps, and you can quickly sample and test yourself without going out
-Mfy Date: Jan 2022
-Expiry Date: Jul 2023
*The attached "long thick cotton swab" can help increase the sample size
*Directly test the cotton swab tip for sampling, no need to use a plastic bottle to mix the test agent and then drop it on the test card,
it is a more direct, more precise and environmentally friendly design.
*After opening the test card, please tear off the horizontal adhesive tape, so that the test card is tightly attached.
*Easy to use, the product introduction has a Chinese instructions
*Chinese and English instructions are included in the package
Package included: 1 set of kits
Lepu Medical Technology ( Beijing ) Co., Ltd was established in 1999. It is specialized in developing, manufacturing and marketing high-tech medical devices and equipment.
Today, Lepu Medical has grown into a global leading medical technology company in the fields of cardiovascular interventions, structural heart diseases, cardiac rhythm management, anesthesia and critical care, in vitro diagnostics and general surgery with products include coronary stents, dilatation balloon catheters, interventional accessories, occlusion devices, mechanical heart valves, electrophysiology catheters, pacemakers, in vitro diagnostic equipment and biomarkers, DSA systems and surgical staplers. In 2009 Lepu Medical successfully went public, and was listed on Chinext Shenzhen StockExchange Market ( stock code: 300003).
As a professional and responsible medical product company, the company once re-exported products to the United States for sale in May 2021 because some distributors did not have permission, and the company took immediate action to recall the batch of products.
This product has been produced so far, and it has been sold to many countries in Europe and Asia.
For details, please refer to the label on the product.
The picture above is for reference only. The real object should be considered as final.