COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

PathoCatch COVID-19 Qualitative PCR Kit

Manufactured by Mylab Discovery Solutions Pvt. Ltd, India - https://mylabdiscoverysolutions.com/

Device identification number

288

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Manual

Physical Support

Cartridge

Target

Nucleic acid

Specimen

Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

Pathogens detected

Coronaviruses (HCoV), SARS-CoV

Lineages detected

B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India),

Commercial Status

Commercialised

Last Update

2021-07-06 02:30:47 CET

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

Method

RT-PCR

Time

180 minutes

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