FDA Import Refusal 799-3123372-0/11/1 — SD Biosensor, Inc.

SD Biosensor, Inc. — FEI 3012133212

The FDA refused shipment 799-3123372-0/11/1 from SD Biosensor, Inc. (South Korea) on Feb 7, 2023. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Feb 7, 2023
Country
South Korea
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
508

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