Devices

DHEA RIA Reagent

Model / Serial
Lot numbers: 991112, 991346, 991584, 991857, 992115, 992359, 992458, 992854 were manufactured at: Beckman Coulter, Diagnostics Systems Laboratories, a Beckman Coulter Company, 445 West Medical Center Blvd, Webster, Texas 77598. Lot numbers: 100115A, 100205A, 100205RA, 100226A, 100226RA, 100319A, 100319RA, 100409A, 100409RA, 100430A, 100430RA, 100521A, 100611A, 100611RA, 100702A, 100723A, 100723B, 100723RA, 100813A, 100813RB, 100813C were manufactured at: Immunotech, Prague, a Beckman Coulter Company, Radiova 1, Praha, 10227, Czech Republic.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
Product Description
DHEA RIA Reagent || The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of DHEA RIA Reagent

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

One device with a similar name

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DHEA RIA Reagent

Model / Serial
DSL-8900 | see letter
Product Description
IVD: Radioimmunoassay, dehydroepiandrosterone (free and sulfate)
Manufacturer
Beckman Coulter Inc.

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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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