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IDS-iSYS Ostase® BAP Control Set
FDA UDIFDA 510(k)EUDAMEDClass I (US FDA UDI)
510(k) K200475
Identity
- Trade Name
- IDS-iSYS Ostase® BAP Control Set FDA UDI
- Generic Name
- Bone alkaline phosphatase (BALP) IVD, control FDA UDI
- Model / Reference
- IS-2830US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169695818 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Bone alkaline phosphatase (BALP) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone alkaline phosphatase (BALP) IVD, control
IDS-iSYS Ostase® BAP Control Set by Immunodiagnostic Systems , Ltd. — Class I — FDA_510K, IVDD — listed in FDA GUDID, FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200475 | Class I | Active |
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems , Ltd.
Sources (3)
- FDA UDI 20bccb44-43bd-441e-89f0-f565674f41f3 58 fields · synced Jun 18, 2026
- FDA 510(k) K200475 1 fields · synced Jun 4, 2026
- EUDAMED 1 fields · synced Jun 2, 2026