Identity
- Trade Name
- INORGANIC PHOSPHOROUS (PHOS) FDA UDI
- Generic Name
- Inorganic phosphate (PO43-) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- PH8048 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273209341 FDA UDI
- FDA Product Code
- CEO FDA UDI
- GMDN Term
- Inorganic phosphate (PO43-) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1580 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
Yes
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
Category: Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Inorganic Phosphorous (phos) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inorganic phosphate (PO43-) IVD, kit, spectrophotometry.
- Alinity — Abbott · Class I
- Atellica CH IP — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT ST218 — Carolina Liquid Chemistries Corp. · Class I
- Alinity — ABBOTT IRELAND · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT CC218 — Carolina Liquid Chemistries Corp. · Class I
- ENVOY 500 PHOSPHORUS REAGENT KIT — VITALSCIENTIFIC
- ADVIA® Chemistry IP Inorganic Phosphorus Reagents — Siemens Healthcare Diagnostics · Class I
- Phosphate (Inorganic) ver.2 — Roche Diagnostics Corp. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 47330d09-8736-4b9a-acb3-f416f5cb22df 32 fields · synced May 30, 2026