Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015189693

FEI Number

3015189693

Entity Name

IMMUNDIAGNOSTIK, INC.

City/State/Country

Manchester, NH, US

Establishment Address

150 Dow Street, Ste 430, Manchester, NH 03101, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Immundiagnostik, Inc. (Owner Number: 10059103)

Owner / Operator Contact Address

150 Dow St, Suite 430, Manchester, NH 03101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lysozyme ELISA IDK® Pancreatic Elastase ELISA IDK Extract® ox-LDL/MDA Adduct ELISA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JMQ	M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)	Clinical Chemistry	Class 1	862.1490	2018-12-18
JNN	P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin	Clinical Chemistry	Class 1	862.1725	2018-11-30
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2018-11-30
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2018-12-18

Official Correspondent

Terance Fisher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Immundiagnostik, Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2009	Roche Diagnostics Corp.	1	Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.

Similar Registrations

Registration Number	Establishment Name	Location
2245285	DRG International, Inc.	Springfield, NJ, US
3005452690	IMMUNDIAGNOSTIK AG	Bensheim Hesse, DE
3002800697	DRG INSTRUMENTS GMBH	MARBURG Hesse, DE
1000191380	BUHLMANN LABORATORIES AG	SCHONENBUCH/BASEL Basel-Landschaft, CH
9614972	SCHEBO BIOTECH AG	GIESSEN Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015189693. Last updated year: 2026. Please use registration number 3015189693 when referencing this establishment in official correspondence.