Devices (same UDI-DI)
2
Certificates
0
Countries
11
Notified Bodies
0
Basic Information
- Primary DI
- 05060169690202
- Basic UDI-DI Code
- 5060169690202W9
- Reference
- IS-2800
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Immunodiagnostic Systems Limited
Additional Description
The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS systems. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget’s disease
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102060399 | BONE METABOLISM TESTS - OTHER |
Available In Countries
🇧🇪 Belgium
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇳🇴 Norway
🇵🇱 Poland
🇸🇪 Sweden
🇬🇧 United Kingdom
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