Devices

Access Ostase Reagent

Model / Serial
37300 | see letter
Product Description
IVD: Bone alkaline phosphate, IC
Manufacturer
Beckman Coulter Inc.
1 Event
- Field Safety Notices about Access Ostase Reagent

Manufacturer

Beckman Coulter Inc.

Manufacturer Parent Company (2017)
Danaher Corporation
Source
SATP

2 devices with a similar name

Learn more about the data here

Access Ostase Calibrator, Access Ostase Quality Control and Access Ostase Reagent

Model / Serial
Manufacturer
N/A

Device Recall Access Ostase Reagent

Model / Serial
Lot Numbers: Expiration dates: 011167 04/30/2011 017561 09/30/2011 014486 7/31/2011
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
Product Description
Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. || The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.
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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