Viramed Biotech AG
PLANEGG Bavaria, DE
VIRAMED BIOTECH AG appears in FDA device records in PLANEGG Bavaria, DE. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Viramed Biotech AG between 2005 and 2022. The busiest year on record is 2005, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2009 | 2 |
| 2017 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220016 | Viramed Borrela All-In-One ViraChip Test Kit | LSR | Substantially Equivalent | |
| K163695 | Borrelia B31 ViraChip IgM Test Kit | LSR | Substantially Equivalent | |
| K163504 | Borrelia B31 ViraChip IgG Test Kit | LSR | Substantially Equivalent | |
| K092693 | VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS | LSR | Substantially Equivalent | |
| K082329 | VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE | LSR | Substantially Equivalent | |
| K051169 | BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT | LSR | Substantially Equivalent | |
| K051071 | VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT | LSR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004181478 | 3004181478 | VIRAMED BIOTECH AG | BEHRINGSTRASSE 11, PLANEGG Bavaria D-82152 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain