Identity
- Trade Name
- IDS-iSYS Ostase® BAP Calibration Verifiers FDA UDI
- Generic Name
- Bone alkaline phosphatase (BALP) IVD, calibrator FDA UDI
- Model / Reference
- IS-2835US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169695825 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Bone alkaline phosphatase (BALP) IVD, calibrator 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, calibrator
IDS-iSYS Ostase® BAP Calibration Verifiers by Immunodiagnostic Systems , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems , Ltd.
Sources (1)
- FDA UDI daa4b2de-1531-4900-8986-4acaf206e443 34 fields · synced Jun 8, 2026