FDA Import Refusal AEK-9607005-4/11/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3012133212

The FDA refused shipment AEK-9607005-4/11/1 from SD Biosensor, Inc. (South Korea) on Aug 24, 2021. The refused product falls under Devices — COVID-19 MULTI-ANALYTE ANTIGEN DEVICE. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal details

Date
Aug 24, 2021
Country
South Korea
Product Category
Devices
Product Code
83QMN COVID-19 MULTI-ANALYTE ANTIGEN DEVICE
Charges
508

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