FDA Import Refusal 799-4967771-2/10002/1 — ALTRUAN GMBH

ALTRUAN GMBH — FEI 3035369407

The FDA refused shipment 799-4967771-2/10002/1 from ALTRUAN GMBH (Germany) on Oct 24, 2025. The refused product falls under Devices — A SIMPLE POINT-OF-CARE DEVICE TO DIRECTLY DETECT SARS-COV-2 VIRAL TARGETS FROM CLINICAL SPECIMENS IN. Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Oct 24, 2025
Country
Germany
Product Category
Devices
Product Code
83QVF A SIMPLE POINT-OF-CARE DEVICE TO DIRECTLY DETECT SARS-COV-2 VIRAL TARGETS FROM CLINICAL SPECIMENS IN
Charges
118,3280

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