FDA Import Refusal 799-8696098-5/11/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3012133212

The FDA refused shipment 799-8696098-5/11/1 from SD Biosensor, Inc. (South Korea) on Sep 9, 2020. The refused product falls under Devices — NON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal details

Date
Sep 9, 2020
Country
South Korea
Product Category
Devices
Product Code
83OTG NON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY
Charges
508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.