FDA Import Refusal 799-5260540-8/11/1 — BioFire Diagnostics, LLC

BioFire Diagnostics, LLC — FEI 3002773840

The FDA refused shipment 799-5260540-8/11/1 from BioFire Diagnostics, LLC (United States) on March 4, 2020. The refused product falls under Devices — MULTIPLEX NUCLEIC ACID ASSAY SYSTEM, VIRAL NUCLEIC ACID IN RESPIRATORY SPECIMENS, MULTIPLE RESPIRATO. Cited charge: 341 This firm has 2 other import refusals on record.

Refusal Details

Date
March 4, 2020
Country
United States
Product Category
Devices
Product Code
83OCC MULTIPLEX NUCLEIC ACID ASSAY SYSTEM, VIRAL NUCLEIC ACID IN RESPIRATORY SPECIMENS, MULTIPLE RESPIRATO
Charges
341