Duns Number:008254708
Device Description: The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use w 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.
Catalog Number
37300
Brand Name
Access Ostase
Version/Model Number
37300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CIN
Product Code Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Public Device Record Key
561fcb7f-82ff-4d26-9843-bdb27323b934
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |