Devices

Dimension Vista Systems LOCI Thyroid Stimulating Hormone (TSH) Reagent

Model / Serial
Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia.
Product Description
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Dimension Vista Systems LOCI Thyroid Stimulating Hormone (TSH) Reagent

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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