FDA Import Refusal 799-5515316-0/20003/1 — Safecare Biotech (Hangzhou) Co.,Ltd

Safecare Biotech (Hangzhou) Co.,Ltd — FEI 3017040656

The FDA refused shipment 799-5515316-0/20003/1 from Safecare Biotech (Hangzhou) Co.,Ltd (China) on Dec 5, 2025. The refused product falls under Devices — OVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Dec 5, 2025
Country
China
Product Category
Devices
Product Code
83QWB OVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2
Charges
508

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