FDA-Device2017-01-04Class II
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
PerkinElmer Health Sciences, Inc.
Hazard
Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Sold states
Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
Affected count
21
Manufactured in
940 Winter St, N/A, Waltham, MA, United States
Products
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0902-2017Don't want to check this manually?
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