Identity
- Trade Name
- PHOENIX DIAGNOSTICS, INC. FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems FDA UDI
- Model / Reference
- 21-107 FDA UDI
- Description
- ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853366007073 FDA UDI
- 510(k) Number
- K020148 FDA UDI
- FDA Product Code
- JGS FDA UDICEM FDA UDICGZ FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 FDA UDI862.1600 FDA UDI862.1170 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
Phoenix Diagnostics, Inc. 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
K020148 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 — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phoenix Diagnostics, Inc.
Sources (1)
- FDA UDI cd8c79cd-d832-4c3f-b241-6d7e8a1e7f49 34 fields · synced May 30, 2026