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

Bfast [FluA/FluB/SARS-CoV-2] RT-PCR kit - for Chronos Dx

Manufactured by BforCure, France - https://www.bforcure.com/

Device identification number

5730

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Chip

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, Other (RdRp gene)

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Chlamydia Pneumoniae, Other (Legionella cherii, Legionella jordanis, Legionella anisa, Legionella longbeachae, Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae, Streptococcus pyogenes, Legionella pneumophila, Streptococcus bovis)

Pathogens detected

Influenza A, Influenza B, SARS-CoV-2

Lineages detected

A.23.1, AT.1, 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.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-10-25 10:07:43 CET

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

Yes

Self Test

Reader Required

Yes

Subcategory

Sample preparation

Method

RT-PCR

Measurement

N.A.

Time

15 minutes

Subclass

N.A.

Detection Principle

Fluorescence

LOD

100 copies/reaction

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