FDA Import Refusal 799-9827864-0/11/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3008959428

The FDA refused shipment 799-9827864-0/11/1 from SD Biosensor, Inc. (South Korea) on Jan 29, 2021. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charges: 237,508 This firm has 5 or more other import refusals on record.

Refusal details

Date
Jan 29, 2021
Country
South Korea
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
237,508

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