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Sentosa SA201 HSV-1/2 PCR Test
VELA OPERATIONS SINGAPORE PTE. LTD. · Model 300216 · UDI-DI 08885013953664
10
510(k) clearances
9
Adverse events
1
Recalls
7
Facilities
Description
Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-12 | DiaSorin Molecular LLC | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.