12 results
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Sources: EU EUDAMED, US FDA
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PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
FDA Enforcement
Class II
·Terminated·PerkinElmer Health Sciences, Inc.·August 13, 2014
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
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·February 1, 2017
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·December 28, 2016
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 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
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·February 1, 2017
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·December 28, 2016
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
FDA Enforcement
Class II
·Terminated·PerkinElmer Health Sciences, Inc.·January 4, 2017
Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.
FDA Enforcement
Class II
·Terminated·PerkinElmer Health Sciences, Inc.·August 13, 2014
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 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
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·February 1, 2017
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·August 2, 2017
PerkinElmer 226 Sample Collection Device
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·June 10, 2020
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
FDA Enforcement
Class II
·Terminated·Perkin Elmer Health Sciences, Inc.·October 30, 2013
PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
FDA Enforcement
Class II
·Terminated·PerkinElmer Health Sciences Canada, Inc.·December 5, 2018