FDA UDI
In Commercial Distribution
🇺🇸 United States
Access Ostase
DI: 15099590232313
·
Model: 37300
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Access Ostase
- Primary DI
- 15099590232313
- Version / Model
- 37300
- Catalog Number
- 37300
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2023-07-26
- Public Version Status
- Update
- Public Device Record Key
- 561fcb7f-82ff-4d26-9843-bdb27323b934
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | Clinical Chemistry | 862.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52932 | Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay | 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590232313 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K994278 | 000 |