Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009236983

FEI Number

3009236983

Entity Name

altona Diagnostics GmbH

City/State/Country

Hamburg, DE

Establishment Address

Moerkenstrasse 12, Hamburg 22767, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

altona Diagnostics GmbH (Owner Number: 10040428)

Owner / Operator Contact Address

Moerkenstrasse 12, Hamburg, DE-HH 22767, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RealStar® ASR HHV-6 Probe RealStar® ASR HHV-6 Primer RealStar® ASR Trichomonas vaginalis Primer RealStar® ASR BKV Primer RealStar® ASR JCV Primer RealStar® ASR Adenovirus Probe RealStar® ASR JCV Probe RealStar® ASR Trichomonas vaginalis Probe RealStar® ASR CMV Probe RealStar® ASR HSV-2 Probe RealStar® ASR HSV-1 Primer RealStar® ASR Parvovirus B19 Primer RealStar® ASR VZV Probe RealStar® ASR CMV Primer RealStar® ASR HSV-2 Primer RealStar® ASR Parvovirus B19 Probe RealStar® ASR HSV-1 Probe RealStar® ASR Adenovirus Primer RealStar® ASR BKV Probe RealStar® ASR VZV Primer RealStar® ASR EBV Probe RealStar® ASR EBV Primer RealStar® GPR PCR Master 1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2012-04-12
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2012-04-12

Official Correspondent

Sven Cramer

US Agent Details

TYLER CARNEY Email: tyler.carney@altona-diagnostics.com Phone: (614) 7061784

Related Public Records

Same Entity

altona Diagnostics GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009236983. Last updated year: 2026. Please use registration number 3009236983 when referencing this establishment in official correspondence.