17 results · 59ms · Sources: EU EUDAMED, US FDA

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Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.

FDA Recall
Terminated ·PerkinElmer LIfe Sciences Inc·Product code JJT·January 8, 2003

Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.

FDA Recall
Terminated ·PerkinElmer Life Sciences Inc·Product code JLJ·June 27, 2003

Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.

FDA Recall
Terminated ·PerkinElmer Life Sciences Inc·Product code JIA·May 30, 2003

Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use

FDA Recall
Terminated ·Perkinelmer Life Sciences, Inc.·Product code CIB·July 28, 2003

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 Recall
Terminated ·Perkinelmer Life Sciences, Inc.·Product code JQW·August 2, 2017

Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.

FDA Recall
Terminated ·PerkinElmer Life Sciences Inc·Product code JIA·May 30, 2003

Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

FDA Recall
Terminated ·Perkinelmer Life Sciences, Inc.·Product code JJN·May 15, 2017

Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.

FDA Recall
Terminated ·PerkinElmer LIfe Sciences Inc·May 16, 2002

Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

FDA Recall
Terminated ·Perkinelmer Life Sciences, Inc.·Product code DHN·July 21, 2003

Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro diagnostic use

FDA Recall
Terminated ·Perkinelmer Life Sciences, Inc.·Product code CIB·July 28, 2003

Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays.

FDA Recall
Terminated ·PerkinElmer Life Sciences Inc·Product code JIA·May 30, 2003

Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

FDA Enforcement
Class II ·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 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

Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

FDA Enforcement
Class II ·Terminated·Perkin Elmer Life Sciences Inc·November 4, 2015

Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000

FDA Recall
Terminated ·Perkin Elmer Life and Analytical Sciences Inc·Product code JIA·January 9, 2004

Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000

FDA Recall
Terminated ·Perkin Elmer Life and Analytical Sciences Inc·Product code JIA·January 9, 2004

Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

FDA Recall
Terminated ·Perkin Elmer Life Sciences Inc Laitun 4 Mustionkatu 6 Turku Finland·Product code JQP·August 24, 2015