Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SArs-CoV-2 Real Time

Manufactured by Nuclear Laser Medicine srl, Italy - www.nlm.it 

Device identification number
2296
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
(UNG) has been introduced in mix to prevent possible carry-over contamination. Endogenous Internal Control is co-extracted and coamplified in order to monitor all the procedure. Available separated software for results automatic interpretation.
Assay Type
Nucleic acid-PCR
Reader Required
No
Method
RT-PCR
Measurement
Qualitative
Positive control
Present, used during the amplifcation phase
Negative control
NTC, which can be extracted with samples or directly amplified

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