Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005452690

FEI Number

3005452690

Entity Name

IMMUNDIAGNOSTIK AG

City/State/Country

Bensheim Hesse, DE

Establishment Address

Stubenwald-Allee 8a, Bensheim Hesse 64625, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Immundiagnostik AG (Owner Number: 10053423)

Owner / Operator Contact Address

Stubenwald-Allee 8a, Bensheim, DE-HE 64625, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IDK® sIgA ELISA Albumin, human Albumin Immunological Test System Alpha-2-macroglobulin Immunological Test System Lysozyme ELISA Chymotrypsin Elisa Chymotrypsin Test System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DAJ	Free Secretory Component, Antigen, Antiserum, Control	Immunology	Class 2	866.5380	2018-12-13
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2020-10-26
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2020-10-26
JMQ	M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)	Clinical Chemistry	Class 1	862.1490	2018-12-13
JKW	N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin	Clinical Chemistry	Class 1	862.1180	2020-10-23
JNN	P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin	Clinical Chemistry	Class 1	862.1725	2016-12-05
JKX	N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin	Clinical Chemistry	Class 1	862.1180	2020-10-26

Official Correspondent

Swantje Holbrook

US Agent Details

Terance Fisher Business: Immundiagnostik, Inc. Email: tfisher@immundiagnostik.com Phone: (888) 4339020

Related Public Records

Same Entity

Immundiagnostik AG

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 3005452690. Last updated year: 2026. Please use registration number 3005452690 when referencing this establishment in official correspondence.