FDA Import Refusal AEK-7876157-1/11/1 — Bionote, Inc.

Bionote, Inc. — FEI 3010847152

The FDA refused shipment AEK-7876157-1/11/1 from Bionote, Inc. (South Korea) on Oct 9, 2020. The refused product falls under Devices — NON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY. Cited charge: 508 This firm has 4 other import refusals on record.

Refusal details

Date
Oct 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.