QPLEX

Primary DI

08800044300089

Basic UDI-DI Code

B-08800044300089

Reference

QMCOVID02

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

QuantaMatrix Inc.

QPLEX COVID-19 Test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and sputum specimens from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally det ectable in nasopharyngeal swab specimens and Sputum during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the Unite d States and its territories are required to report all test results to the appropriate public h ealth authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical ob servations, patient history, and epidemiological information.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).