FDA Import Refusal AEK-9661710-2/11/1 — Abbott Rapid Diagnostics Jena GmbH

Abbott Rapid Diagnostics Jena GmbH — FEI 3016704892

The FDA refused shipment AEK-9661710-2/11/1 from Abbott Rapid Diagnostics Jena GmbH (Germany) on Aug 30, 2021. 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
Aug 30, 2021
Country
Germany
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.