The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), and 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 Paget's disease.
Access Ostase - 37300
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of bone alkaline phosphatase (BALP) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used as a marker for osteoblastic activity to aid in the diagnosis and/or management of metabolic bone diseases (e.g., osteoporosis, Paget’s disease).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CIN
Device Name: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1050
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 15099590232313
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A