Viramed Biotech AG
DE-MF-000020368 · Germany · Planegg
Viramed Biotech AG is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Syphilis IgG Antibodies, Syphilis IgG Kit, Syphilis IgM Antibodies, Syphilis IgM Kit.
Devices declared under this manufacturer
- Incubation tray for ViraStripe® and ViraBlot tests, 8 channels, black
- Treponema + VDRL ViraChip IgG Deca Kit
- Treponema + VDRL ViraChip IgM Antigen Coated Wells
- ViraChip Chromogen / Substrate Solution
- ViraChip Sample Buffer
- ViraChip Software
- ViraChip Wash Buffer Plus
- ViraChip® / ViraStripe® / ViraBlot Avidity Reagent
- ViraChip® / ViraStripe® / ViraBlot Diluent/Wash Buffer
- ViraChip® / ViraStripe® / ViraBlot Diluent/Wash Powder
- ViraChip® AP-Anti-Human IgA Conjugate
- ViraChip® AP-Anti-Human IgM Conjugate
Showing 12 of 47 declared devices.
Catalogue references include V-TVCMAC, V-UVCAKI, V-UVCMKI, V-UVCUPP80, V-UVNPPC, V-UVNUAV.
European nomenclature codes declared: W0105900201, W0580, W0105010304, W0105010303, W02050107, W02050292.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | VIRAMED BIOTECH AG (DE) · FDA 3004181478 |
| Devices in EUDAMED | 47 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | VIRAMED BIOTECH AG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2016-11-02 |
Licence types: System (4).
Licensed under: BORRELIA VIRACHIP IGG TEST KIT, BORRELIA VIRACHIP IGM TEST KIT, BORRELIA B31 VIRACHIP IGG TEST KIT, BORRELIA B31 VIRACHIP IGM TEST KIT.
North American profile: Both markets. Viramed Biotech AG is registered in both the United States and Canada.