FDA Import Refusal 799-2521387-3/1/1 — Standard Diagnostics, Inc.

Standard Diagnostics, Inc. — FEI 3010391450

The FDA refused shipment 799-2521387-3/1/1 from Standard Diagnostics, Inc. (South Korea) on Nov 19, 2015. The refused product falls under Devices — TEST, QUALITATIVE, DETECTION OF DENGUE IGM AND IGG ANTIBODIES. Cited charges: 118,3280,508 This firm has 5 or more other import refusals on record.

Refusal details

Date
Nov 19, 2015
Country
South Korea
Product Category
Devices
Product Code
83NWY TEST, QUALITATIVE, DETECTION OF DENGUE IGM AND IGG ANTIBODIES
Charges
118,3280,508

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