Identity
- Trade Name
- Phoenix Diagnostics FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- LiquiCV MA - Multi-Analyte Linearity Control FDA UDI
- Model / Reference
- PH5020 FDA UDI
- Description
- LiquiCV MA - Multi-Analyte Linearity Control FDA UDI
Identifiers
- Catalog Number
- PH5020 FDA UDI
- Primary DI / UDI-DI
- 00852676007100 FDA UDI
- 510(k) Number
- K904075 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, control 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
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
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Multiple-type clinical chemistry analyte profile IVD, control
Phoenix Diagnostics by Phoenix Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K904075 also covers:
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
- Phoenix Diagnostics, Inc.
Sources (1)
- FDA UDI 24600f7f-ac0f-402e-b3d5-7a64962a6b4d 38 fields · synced May 30, 2026