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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

IFU NovaPrime IVD RNA Extraction AE1 RTU

Manufactured by Eurofins GeneScan Technologies GmbH, Hungary

Device identification number
2665
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Semi-automated
Physical Support
Microtiter plate
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
1. Description of the kit The GSD NovaPrime IVD RNA Extraction AE1 RTU kit was designed to extract RNA from SARS-CoV-2 viruses with automated extraction instruments such as the KingFisher Flex from Thermo Scientific, Maelstrom 9600 from TAN Bead, the Auto-Pure96 Nucleic Acid Purification System from Allsheng or the AU1001-96 from BioTeke. The kit contains all buffers and chemicals for the RNA extraction procedure and yields RNA of high quality and quantities suitable for further analytical downstream applications (e.g. RT qPCR), Molecular grade solvents (Ethanol and Isopropanol), as well as plastic consumables have to be provided by the testing laboratory. 2. Purpose and Scope of the kit The kit can be used to extract viral RNA from SARS-CoV-2 virus from clinical swabs (such as dry clinical swabs) and their transport medium (such as universal transport medium). The kit can also be used with gargling solution of 0.9% NaCL and crude saliva samples as sample matrix. Total processing time for 96 extractions is about 2 h with hands on time of approximately 60 min. The kit should be regarded as “professional use only” and should only be used by trained personal. The kit should be regarded as “for in-vitro diagnostic use only”.
Assay Type
Unknown
Subcategory
Extraction kit
Method
Other ()

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