Identity
- Trade Name
- ISE Calibrator 1 FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- To provide calibration points for the Na+, K+, and CI- electrodes on the Tokyo Boeki Biolis 24i and Prestige 24i Systems. FDA UDI
- Model / Reference
- TB-20270477D FDA UDI
- Description
- To provide calibration points for the Na+, K+, and CI- electrodes on the Tokyo Boeki Biolis 24i and Prestige 24i Systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403018567 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple electrolyte IVD, calibrator
ISE Calibrator 1 by DIAMOND DIAGNOSTICS Inc — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DIAMOND DIAGNOSTICS Inc
Sources (2)
- FDA UDI dbcc0d39-a580-4f4d-8b1e-e96bbd27a65a 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 5, 2026