FDA UDI
In Commercial Distribution
🇺🇸 United States
Access Ostase Calibrators
DI: 15099590677381
·
Model: B83876
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Access Ostase Calibrators
- Primary DI
- 15099590677381
- Version / Model
- B83876
- Catalog Number
- B83876
- 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
- ba0c70af-28b5-4b65-94b1-16760fd6e86c
Device Description
The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
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 |
|---|---|---|---|---|
| JIS | Calibrator, Primary | Clinical Chemistry | 862.1150 | 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 | 15099590677381 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K994278 | 000 |