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RDT / DORT- COVID-19

BTE25TESTCOV

Hangzhou Laihe Biotech/ Lyhe’s Combined IgM/IgG (Colloidal Gold) Antibody Test Kit for Novel Coronavirus (2019-nCoV) is intended for the qualitative detection of IgM/IgG antibodies against novel coronavirus in serum, plasma or blood from patients suspected of 2019-nCoV infection. The kit is an in vitro diagnostic device, intended for professional use only.

  • Fast detection: Result in 10 minutes
  • Simple procedure, achievable in medical biology laboratories according to the conditions described in the decree of May 20, 2020. Following the publication in the JORF of July 11, 2020 allowing the use of these rapid serological tests SARS-CoV-2 as DORT by health professionals other than biologists these rapid tests can be performed in city medicine. Sold per 25-unit carton – 25 cassettes; 25 lancets; 25 pipettes; 2 buffer vials (diluent); 25 disinfectant cottons; 1 leaflet

High accuracy:

  • Sensitivity [92% - 96.37%] and specificity [99.05% - 100%]

Product conforming to the specifications of the French High Authorityof Health.

Listed by the French Ministry of Health.

  • CE

More details

Advantages of the product:

  • Early Detection
  • Simple procedure
  • High accuracy
  • Product conforming to the specifications of the French High Authority of Health
  • Eligible under the conditions of support and listed by the Ministry of Health
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CharacteristicValue
PackagingBox of 25 kits

In-vitro diagnostic medical device. Classification: other tests.

Carefully read the instructions in the package leaflet that accompanies the medical device. Documentation for the health professional. Non contractual photographs.

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