Data / Medical devices / Germany / Viramed Biotech AG
Viramed Biotech AG: FDA-registered device maker in PLANEGG Bavaria, Germany, 5 510(k) clearances
Viramed Biotech AG is registered with the FDA (registration 3004181478) in PLANEGG Bavaria, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004181478
- Address
- Behringstrasse 11, PLANEGG Bavaria, Germany, D-82152
- Owner or operator
- VIRAMED BIOTECH AG (9062838)
- Roles
- Manufacturer
- First device listed
- April 16, 2004
- Registered through
- 2026
- Brand names listed
- BORDETELLA SPECIES VIRASTRIPE, Borrelia All-In-One ViraChip Test Kit, Borrelia B31 IgG ViraStripe, Borrelia B31 IgM ViraStripe, Borrelia B31 ViraChip IgG Test Kit, Borrelia B31 ViraChip IgM Test Kit, ViraCam, ViraChip Reader
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, B. Pertussis | GOX | 1 | Manufacturer | accessdata.fda.gov |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | 1 | Manufacturer | accessdata.fda.gov |
| Reagent, Borrelia Serological Reagent | LSR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2022 | K220016 | Viramed Borrela All-In-One ViraChip Test Kit | LSR | Substantially Equivalent | Viramed Biotech AG | accessdata.fda.gov |
| August 22, 2017 | K163695 | Borrelia B31 ViraChip IgM Test Kit | LSR | Substantially Equivalent | Viramed Biotech AG | accessdata.fda.gov |
| July 12, 2017 | K163504 | Borrelia B31 ViraChip IgG Test Kit | LSR | Substantially Equivalent | Viramed Biotech AG | accessdata.fda.gov |
| November 25, 2009 | K092693 | VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS | LSR | Substantially Equivalent | Viramed Biotech AG | accessdata.fda.gov |
| August 5, 2009 | K082329 | VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE | LSR | Substantially Equivalent | Viramed Biotech AG | accessdata.fda.gov |
Compare with other makers
- All makers of Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- All makers of Reagent, Borrelia Serological Reagent
- All makers of Antigen, B. Pertussis
Updated August 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.