Devices

Device Recall DSL108000 Active IPTH ELISA

Model / Serial
Lot Numbers: 891198, 990980, 991448
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
Product Description
Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 || The DSL-10-8000 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 Device Recall DSL108000 Active IPTH 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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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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