Hangzhou Clongene Biotech Co., Ltd. is a high-tech enterprise specialized in biological raw materials and in vitro diagnostic products.
Founded in 2004, Clongene is equipped with state-of-the-art ISO 13485:2016 accredited- China GMP compliant R&D and manufacturing facilities covering 19,000 square meters in Hangzhou, China. Our products have obtained CE certificates, FSC certificates and US FDA 510(k) Clearances.
Our products main lines:
• Colloidal gold immunoassay
• Chemiluminescence immunoassay (CLIA)
• Fluorescence immunoassay (FIA)
• Molecular diagnosis- PCR
Clongene is a leading manufacturer in technology and in vitro diagnostic products, with a solid reputation and diversified services with superior flexibility to professional distributors and partnering affiliates to the global market.
COVID-19 Antigen Rapid Test
- CE certified
- Refundable according to TestV.
- Evaluated by Paul-Ehrlich-Institut PEI
- BfArM listed with the number AT 079/20 on the list of antigen tests for SARS-CoV-2
- PZN: 17233501, PPN: 111723350176
Packing Specification: 25 test/ box.
Storage Condition: Store as packaged in the sealed pouch at the temperature (4-30℃ or 40-86℉).
Period of Validity: 24 months.
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25 sample collection tubes
1 working station
1. CE certification
2. Instant result at 15 minutes
3. Easy to collect samples
4. Results are clearly visible
5. No equipment required
6. Suitable for large-scale rapid screening
The product is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique.
If the specimen contains SARS-CoV-2 antigen, a colored test line (T) would be visible in the result window. Absence of the T line suggests a negative result.
The product is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab.