VIRAMED BIOTECH AG

FDA Device Registration & Listing · PLANEGG Bavaria, DE · Registration 3004181478

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004181478
FEI Number
3004181478
Entity Name
VIRAMED BIOTECH AG
City/State/Country
PLANEGG Bavaria, DE
Establishment Address
BEHRINGSTRASSE 11, PLANEGG Bavaria D-82152, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
VIRAMED BIOTECH AG (Owner Number: 9062838)
Owner / Operator Contact Address
BEHRINGSTRASSE 11, --, PLANEGG, DE-NOTA D-82152, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K092693
PMA Number
N/A

All Registered Proprietary Names

Borrelia B31 ViraChip IgG Test Kit ViraCam ViraChip Reader Borrelia All-In-One ViraChip Test Kit BORDETELLA SPECIES VIRASTRIPE Borrelia B31 IgM ViraStripe Borrelia B31 ViraChip IgM Test Kit Borrelia B31 IgG ViraStripe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2017-11-27
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2014-01-23
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2022-09-06
GOX Antigen, B. Pertussis Microbiology Class 1 866.3065 2004-04-16
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2012-11-06
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2017-11-27
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2012-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

Leonard Rollins Business: Viralab Inc Email: l.rollins@viralab.com Phone: (507) 2084044

Related Public Records

Same Entity

VIRAMED BIOTECH AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K915332 Ciba Corning Diagnostics Corp. MODEL 795 FLUOROMETER/DENSITOMETER 1992-02-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004181478. Last updated year: 2026. Please use registration number 3004181478 when referencing this establishment in official correspondence.
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