Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR)
Manufactured by Wuhan HealthCare Biotechnology Co. Ltd., China - http://www.healthcare-biotech.com/
Device identification number
1971
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites. for more information, please contact at cs@healthcare-bio.com
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Subclass
JRC-S
LOD
500 cpm
Positive control
100 % (coincidence rate of positive controls is 100%.)
Negative control
100 % (coincidence rate of negative controls is 100%.)
Notes
New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements