FDA Import Refusal HTD-9350995-0/72/1 — ORGENTEC Diagnostika Gmbh

ORGENTEC Diagnostika Gmbh — FEI 3003232042

The FDA refused shipment HTD-9350995-0/72/1 from ORGENTEC Diagnostika Gmbh (Germany) on Jul 22, 2025. The refused product falls under Devices — ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS. Cited charge: 508 This firm has 2 other import refusals on record.

Refusal Details

Date
Jul 22, 2025
Country
Germany
Product Category
Devices
Product Code
82LJM ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
Charges
508

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