Identity
- Trade Name
- Phoenix Diagnostics FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- Calibrator 1 for Tokyo Boeki BiOLiS Series Chemistry Systems FDA UDI
- Model / Reference
- 23-101 FDA UDI
- Description
- Calibrator 1 for Tokyo Boeki BiOLiS Series Chemistry Systems FDA UDI
Identifiers
- Catalog Number
- 23-101 FDA UDI
- Primary DI / UDI-DI
- 00853366007363 FDA UDI
- FDA Product Code
- JIX 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 420 Milliliter FDA UDI
Category: Multiple electrolyte IVD, calibrator
Phoenix Diagnostics by Phoenix Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AU — Beckman Coulter, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Phoenix Diagnostics, Inc.
Sources (1)
- FDA UDI 1dbc93d4-ff92-42f2-bd57-edc2058c895e 37 fields · synced Jun 1, 2026