VALIDATE® LP Test Set
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Basic Information
- Primary DI
- 00859110005746
- Basic UDI-DI Code
- B-00859110005746
- Reference
- 501ab
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE LP Calibration Verification / Linearity Test Kit (U.S. Patent #7,244,618 and Canadian Patent #2,579,001) solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: human high density lipoprotein (HDL) and human low density lipoprotein (LDL). Test kits also contain APOA and APOB as structural elements of the HDL and LDL micelles.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050202 | LIPID CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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