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

PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay

Manufactured by PerkinElmer Inc, United States - www.perkinelmer.com/

Device identification number

311

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Manual

Target

Nucleic acid

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Assay Type

Nucleic acid-PCR

Method

RT-PCR

LOD

20 copies/ml (20 copies/ml)

Positive control

yes

Negative control

yes

Throughput

single tubes

Notes

https://perkinelmer-appliedgenomics.com/home/products/sars-cov-2-real-time-rt-pcr-assay-ce-ivd/

Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2
Clinically practiced and commercially viable nanobio engineered analytical methods for COVID-19 diagnosis
No evidence of SARS-CoV-2 RNA among blood donors: A multicenter study in Hubei, China
Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020

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