Devices

Active I PTH ELISA

Model / Serial
Lot Numbers: 992751
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation
Product Description
Active I-PTH ELISA, Part Number: DSL-10-8000 || The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Active I PTH ELISA

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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