FDA Import Refusal 799-3132488-6/10003/1 — Zhejiang Orient Gene Biotech

Zhejiang Orient Gene Biotech — FEI 3008517993

The FDA refused shipment 799-3132488-6/10003/1 from Zhejiang Orient Gene Biotech (China) on Jan 9, 2026. The refused product falls under Devices — COVID-19 TEST HOME COLLECTION KIT DEVICES. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Jan 9, 2026
Country
China
Product Category
Devices
Product Code
83QLW COVID-19 TEST HOME COLLECTION KIT DEVICES
Charges
508

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