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 114/21 on the list of antigen tests for SARS-CoV-2
- PZN: 17292113 , PPN: 111729211309
Packing Specification: 20 test/ box.
Storage Condition: Store as packaged in the sealed pouch at the temperature (4-30℃ or 40-86℉).
Period of Validity: 24 months.
Box Size: 268*124*65mm.
|what contains in a box||box dimention and weight||what contains in a carton||carton dimension and weight|
|20 foil pouches|
20 Extraction Reagents: ampoule containing 0.3 mL of extraction reagent
20 Saliva Collectors
20 Collection tubes
1 Work Station
1 Package Insert
1. Instant result at 15 minutes
2. Easy to collect samples
3. Results are clearly visible
4. No equipment required
5. Suitable for large-scale rapid screening
The COVID-19 Antigen Rapid Test (Saliva) is a lateral flow immunoassay based on the principle of double-antibody sandwich technique.
A colored test line (T) would be visible in the result window, if SARS-CoV-2 antigens are present in the specimen. 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 saliva from individuals who are suspected of COVID-19 by their healthcare provider.