Identity
- Trade Name
- Phoenix Diagnostics FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- ISE Standard Low for Roche / Hitachi Chemistry Systems FDA UDI
- Model / Reference
- 16-205 FDA UDI
- Description
- ISE Standard Low for Roche / Hitachi Chemistry Systems FDA UDI
Identifiers
- Catalog Number
- 16-205 FDA UDI
- Primary DI / UDI-DI
- 00853366007219 FDA UDI
- 510(k) Number
- K013451 FDA UDI
- FDA Product Code
- JIX FDA UDIJGS FDA UDICGZ FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI862.1665 FDA UDI862.1170 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
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
Dimensions & Sizes
- Size
- Total Volume — 20 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
Similar devices
Also classified as Multiple electrolyte IVD, calibrator.
- Alinity — Abbott · Class II
- Electrolyte Standard Kit — VERICHEM LABORATORIES, INC. · Class II
- Calibrator 2 — TOKYO BOEKI MEDISYS INC. · Class II
- Alfa Wassermann — Alfa Wassermann, Inc.
- Dimension® QuikLYTE® Integrated Multisensor Standard A — Siemens Healthcare Diagnostics · Class I
- ISE Calibrator 2 — DIAMOND DIAGNOSTICS Inc · Class II
- AU — Beckman Coulter, Inc. · Class II
- AU — Beckman Coulter, Inc. · Class II
Cleared under the same submission
K013451 also covers:
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
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 b31c4337-c0f0-4199-bb57-8d9ae663b5a8 38 fields · synced May 30, 2026