VALIDATE® GC1 Test Set
Basic Information
- Primary DI
- 00859110005203
- Basic UDI-DI Code
- B-00859110005203
- Reference
- 1100bc
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE GC 1 Calibration Verification / Linearity Test Kit 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: Set 1: albumin (ALB), blood urea nitrogen (BUN), calcium (CA), chloride (CL), cholesterol (CHOL), creatinine (CREAT), glucose (GLU), lactate (LAC), lithium (LITH), magnesium (MG), sodium (NA), phosphorus (PHOS), potassium (K), total protein (TP) and triglyceride (TRIG). Set 2: blood urea nitrogen (BUN), glucose (GLU) and phosphorus (PHOS)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050102 | UNASSAYED MULTICOMPONENT CONTROLS (CC) |
| W0101050101 | ASSAYED MULTICOMPONENT CONTROLS (CC) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).