Eu Ivdd
Eu Ivd General
On The Market
A-Gene Metabolic kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-052004235002095U
- Basic UDI-DI Code
- B-052004235002095U
- Reference
- Ref.007
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
Additional Description
The A-Gene Metabolic kit is an in vitro diagnostic product, which includes genetic analysis of a buccal swab sample and recording of phenotypic characteristics of the individual in order, with the help of interpretive analysis software and the provision of personalised reporting, to guide clinical decisions on nutrient response to diet and weight management for the prevention of metabolic diseases or signs/systemic symptoms, disorders and/or diseases related to dietary habits. The A-Gene Metabolic kit is intended to be used and interpreted by Healthcare Professionals for an adult population.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries