International Medical Devices Database

Manufacturer Address
PerkinElmer Health Sciences, Inc.
Manufacturer Parent Company (2017)
Perkin Elmer Inc.
Source
USFDA
1 Event
- Recall of 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

One device in the database

EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determi...

Model / Serial
Lot Number: 1065060401
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
MA, AK
Product Description
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

2 manufacturers with a similar name

Learn more about the data here

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

PerkinElmer Health Sciences, Inc.

Manufacturer Address
PerkinElmer Health Sciences, Inc., 17 P & N Drive, Greenville SC 29611
Manufacturer Parent Company (2017)
Perkin Elmer Inc.
Source
USFDA

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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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