FDA Import Refusal AEK-5970157-1/11/1 — Edan Instruments, Inc.

Edan Instruments, Inc. — FEI 3003971136

The FDA refused shipment AEK-5970157-1/11/1 from Edan Instruments, Inc. (China) on Jan 23, 2025. The refused product falls under Devices — MERS-COV AND COMMON RESPIRATORY PATHOGENS MULTIPLEX NUCLEIC ACID DETECTION SYSTEM. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Jan 23, 2025
Country
China
Product Category
Devices
Product Code
83PZF MERS-COV AND COMMON RESPIRATORY PATHOGENS MULTIPLEX NUCLEIC ACID DETECTION SYSTEM
Charges
118,508

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