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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LifeReady 1000 automatic integrated gene detection system

Manufactured by Hangzhou LifeReal Biotechnology Co. Ltd., China - http://www.lifereal.com.cn/en/ 

Device identification number
2556
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Fully automated (robot)
Physical Support
Cartridge
Specimen
Nasal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, Mycobacterium Tuberculosis, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
AIGS is the fully integrated system for fast molecular diagnostics, which combines the nucleic acids extraction and realtime PCR amplification, by using the microfluidic cartridge preassembled kit to realize the fully integrated gene data analysis for the samples.It can be widely used for many kinds of gene detection, such as the clinical diagnostic market, food safety, agriculture, army and public security. Since 2020, the system with Covid19 kits are CE IVD marked and were sold more than dozens of countries with millions of sample tested.
Assay Type
Unknown
Reader Required
No
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
90 minutes
LOD
250 cpu

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