FDA-Device2017-02-01Class III
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
PerkinElmer Health Sciences, Inc.
Hazard
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Sold states
Worldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,
Affected count
1 US ; 3 OUS
Manufactured in
940 Winter St, N/A, Waltham, MA, United States
Products
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2017Don't want to check this manually?
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