FDA Import Refusal 85N-0197998-4/50002/2 — Runbio Biotech Co., Ltd.

Runbio Biotech Co., Ltd. — FEI 3005216656

The FDA refused shipment 85N-0197998-4/50002/2 from Runbio Biotech Co., Ltd. (China) on Oct 14, 2026. The refused product falls under Devices — KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER. Cited charge: 341 This firm has 2 other import refusals on record.

Refusal Details

Date
Oct 14, 2026
Country
China
Product Category
Devices
Product Code
75LCX KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
Charges
341