Sentosa SA ZIKV RT-PCR Test

Primary DI

08885013953985

Basic UDI-DI Code

B-08885013953985

Reference

300614

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA ZIKV RT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus (ZIKV) in serum, EDTA plasma or urine (collected alongside a patient-matched serum or plasma specimen) from individual patients. Test results are for the identification of ZIKV RNA. ZIKV RNA is generally detectable in serum and urine during the acute phase of infection and up to 14 days following onset of symptoms, if present. Positive results are indicative of current ZIKV infection. Laboratories are required to report all positive results to the appropriate public health authorities. Negative results do not preclude ZIKV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Sentosa® SA ZIKV RT-PCR Test is configured for automated workflow using the Sentosa® SX101 instrument, in conjunction with the Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument (ABI 7500 Fast Dx) or the Sentosa® SA201. Sentosa® SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for extraction.

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