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

SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip Method)

Manufactured by CapitalBio Technology, China - http://en.capitalbiotech.com/en/index.html

Device identification number

2619

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Lab-based, Near POC / POC

Physical Support

Biochip

Target type

Nucleic acid

Specimen

Nasal swab, Nasopharyngeal swab, Throat swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

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.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Postive result delivered within 35 minutes. Test report issued within 45 minutes.

Assay Type

Nucleic acid-Other

Reader Required

Method

LAMP

Measurement

Qualitative

Time

45 minutes

Subclass

JRC-S

LOD

150 cpm

Throughput

Lab-on-chip

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