Devices

Device Recall Specimen Gate Laboratory eReports

Model / Serial
Software Version 1.0
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
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
Product Description
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
Manufacturer
PerkinElmer Health Sciences, Inc.
1 Event
- Recall of Device Recall Specimen Gate Laboratory eReports

Manufacturer

PerkinElmer Health Sciences, Inc.

Manufacturer Address
PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
Manufacturer Parent Company (2017)
Perkin Elmer Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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