FDA Import Refusal AEK-7164170-5/11/1 — RAPIGEN INC

RAPIGEN INC — FEI 3016790087

The FDA refused shipment AEK-7164170-5/11/1 from RAPIGEN INC (South Korea) on May 26, 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
May 26, 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.