Urine/CSF Albumin
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Basic Information
- Primary DI
- 15099590020422
- Basic UDI-DI Code
- 150995902B46435RX
- Reference
- B46435
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Beckman Coulter Ireland Inc.
Additional Description
Urine/CSF Albumin reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative measurement of albumin in Urine and CSF (Cerebrospinal Fluid) using the automated Beckman Coulter AU/DxC AU analyzers. Measurement of albumin in urine is intended to be used as an aid in the diagnosis of kidney diseases. Measurement of albumin in CSF is intended to be used as an aid in the diagnosis of Central Nervous System (CNS) disorders.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010309 | ALBUMIN (IC) INCL. UALBUMIN |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).