Phosphorus Reagent (PHS 2 x300)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- Phosphorus Reagent (PHS 2 x300) EUDAMEDSynchron FDA UDI
- Generic Name
- Inorganic phosphate (PO43-) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Phosphorus Reagent (PHS 2 x300) EUDAMEDFDA UDI
- Model / Reference
- A09426 EUDAMEDFDA UDI
- Description
- Phosphorus Reagent (PHS 2 x300) FDA UDI
Identifiers
- Catalog Number
- A09426 FDA UDI
- Primary DI / UDI-DI
- D-A09426UC EUDAMED15099590201364 FDA UDI
- Basic UDI-DI
- B-A09426UC EUDAMED
- FDA Product Code
- CEO FDA UDI
- EMDN Code
- W01010307 PHOSPHATE INORGANIC / PHOSPHORUS EUDAMED
- GMDN Term
- Inorganic phosphate (PO43-) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1580 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Inorganic phosphate (PO43-) IVD, reagent
Phosphorus Reagent (PHS 2 x300) by Beckman Coulter, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inorganic phosphate (PO43-) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Phosphorus UV, 2 x 100 mL — Chronolab Systems, S.L. · IVD General
- Liquick Cor-PHOSPHORUS 30 — PZ CORMAY Spółka Akcyjna · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Pointe Scientific, Inc. Phosphorus — POINTE SCIENTIFIC, INC. · Class I
- ACCENT-300 PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
- Alinity — Abbott · Class I
- Fosforo UV — GIESSE DIAGNOSTICS SRL · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-A09426UC | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED baf850fb-c065-4792-98ca-9b7e88cb2426 61 fields · synced Jun 20, 2026
- FDA UDI 6916a0b5-78db-4aa8-bfd6-194c78b96766 34 fields · synced May 27, 2026