Lactate
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Basic Information
- Primary DI
- 15099590010898
- Basic UDI-DI Code
- 150995901OSR6193ML
- Reference
- OSR6193
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Beckman Coulter Inc.
Additional Description
Lactate reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative enzymatic colour measurement of lactate in human plasma and cerebrospinal fluid (CSF) using the automated Beckman Coulter AU/DxC AU analyzers. Measurement of lactate in plasma is intended to be used as an aid in the diagnosis of lactic acidosis. Measurement of lactate in CSF is intended to be used as an aid in the diagnosis of a range of central nervous system (CNS) disorders.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01019099 | CLINICAL CHEMISTRY REAGENTS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).