Identity
- Trade Name
- Dimension® Flex® reagent cartridge PHOS FDA UDI
- Generic Name
- Inorganic phosphate (PO43-) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Phosphorus Flex® reagent cartridge, 480 tests FDA UDI
- Model / Reference
- 10720277 FDA UDI
- Description
- Phosphorus Flex® reagent cartridge, 480 tests FDA UDI
Identifiers
- Catalog Number
- DF61A FDA UDI
- Primary DI / UDI-DI
- 00630414594484 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
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
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
Dimension® Flex® reagent cartridge PHOS by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ENVOY 500 PHOSPHORUS REAGENT KIT — VITALSCIENTIFIC
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- Phosphate 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 0555935c-b0e3-4e4d-8e0d-9133facece42 36 fields · synced May 30, 2026