Macurra SARS-CoV-2 PCR Kit
Manufactured by Diazyme Laboratories, United States - www.diazyme.com/
Device identification number
1417
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.diazyme.com/images/covid19/5-eua200065-a001-maccura-sars-cov-2-fluorescent-pcr-kit-ifu.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
1000 copies/ml
Positive control
MS2 based pseudo-virus containing ORF1ab, N, and E target gene fragments(5.0x103copies/mL)
Negative control
DEPC-treated wate
Clinical Sensitivity
100 %
Clinical Specificity
96.7 %
Notes
Multiplexed assay primers/probes for ORF1ab, N, and E genes
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