FDA Import Refusal 799-6974197-5/12/1 — SHENZHEN HOTGEN BIOTECH CO

SHENZHEN HOTGEN BIOTECH CO — FEI 3036391317

The FDA refused shipment 799-6974197-5/12/1 from SHENZHEN HOTGEN BIOTECH CO (China) on Apr 17, 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: 118,237,3280,508

Refusal Details

Date
Apr 17, 2025
Country
China
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
118,237,3280,508

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