8 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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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
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
JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.
FDA Enforcement
Class III
·Terminated·Perkinelmer Life Sciences, Inc.·March 7, 2018
PerkinElmer 226 Sample Collection Device
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·June 10, 2020