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

NeoPlex™ COVID-19 FAST

Manufactured by GeneMatrix Inc., South Korea - www.genematrix.net/

Device identification number

2838

CE Marking

✓Yes

HSC common list (RAT)

×No

Target type

Nucleic acid

Specimen

Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

All detailed specification and kit's information will be provided in additional IFU.

Assay Type

Nucleic acid-PCR

Reader Required

Yes

Method

RT-PCR

Measurement

Quantitative

Time

45 minutes

LOD

8 cpu

Analytical Sensitivity

100 %

Clinical Sensitivity

100 %

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