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Immundiagnostik AG

Germany·DE-MF-000020905

Last updated September 17, 2026

What Immundiagnostik AG makes

Immundiagnostik AG manufactures nucleic acid extraction and isolation kits, PCR-based diagnostic assays for respiratory and bacterial pathogens, and various ELISA-based tests for biomarkers such as calprotectin, C-reactive protein, vitamins, and ferritin. The company also produces rapid diagnostic tests for cardiac troponin and fecal occult blood, alongside laboratory reagents like wash buffers.

The company is based in Germany, and its product portfolio consists of devices categorized as Class A, Class B, IVD General, and IVD devices for self-testing. These products are listed in the EUDAMED database.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

Where is Immundiagnostik AG based?

Immundiagnostik AG is based in Germany. This information is provided directly by the company's registration data, which identifies the country of origin as DE.

What types of medical devices does Immundiagnostik AG manufacture?

The company manufactures a diverse range of products, primarily focusing on nucleic acid extraction and isolation kits. Their portfolio also includes PCR-based diagnostic assays for respiratory and bacterial pathogens, ELISA-based tests for biomarkers like calprotectin, CRP, vitamins, and ferritin, as well as rapid diagnostic tests for cardiac troponin and fecal occult blood.

How are the devices from Immundiagnostik AG classified?

The devices produced by Immundiagnostik AG fall into several categories, including Class A, Class B, IVD General, and IVD devices for self-testing. These classifications reflect the regulatory framework under which the specific diagnostic products are managed.

Where can I find a list of the devices manufactured by Immundiagnostik AG?

The devices manufactured by Immundiagnostik AG are listed in the EUDAMED database. This is the official European database for medical devices, which serves as the central repository for information regarding devices available on the market.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Germany
Address: 8a, Stubenwald-Allee , Bensheim, Germany
Website: www.immundiagnostik.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +496251701900
PRRC Contact: Franz Paul Armbruster
EUDAMED SRN: DE-MF-000020905
FDA FEI Number: 3005452690
DUNS Number: 321663841

Catalogue (413)

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Device	Model / Reference	Registries	Class	Status
Preventis SmarTest Pro® Vitamin D	PST80100GP	EUDAMED	IVD General	Active
Dao-Rea (3h)	K 8220.2	EUDAMED	IVD General	Active
Preventis SmarTest® Vitamin D Home	PST80100EP04	EUDAMED	IVD General	Active
CRP (C-reactive Protein) (1-point-calibration) ELISA	K 9720s	EUDAMED	IVD General	Active
IDK® Hemoglobin (human) ELISA	K 7816D	EUDAMED	IVD General	Active
IDK® α1-Antitrypsin Clearance ELISA	K 6752	EUDAMED	IVD General	Active
MutaPLEX® HSV/VZV, PCR	KG190696	EUDAMED	IVD General	Active
PreventID® Dermatophyte	KSTDE001GP.01	EUDAMED	IVD General	Active
PreventID® Dermatophyte	KSTDE001GP5.02	EUDAMED	IVD General	Active
Idk® Dao Elisa	Y8500	EUDAMED	Class B	Active
IDK® Hemoglobin/Haptoglobin Complex ELISA	K 7817D	EUDAMED	IVD General	Active
MutaREAL® PAI-1	KF291932	EUDAMED	IVD General	Active
PreventID® CalDetect® 50/200	KST11003TP	EUDAMED	IVD General	Active
β-Defensin 2 ELISA	K 6500.20	EUDAMED	IVD General	Active
MutaPLATE® PAI-1	KF191932	EUDAMED	IVD General	Active
MutaPlex® Coronavirus, PCR	KG192696	EUDAMED	IVD General	Active
PreventID® hCG	KST04112GP	EUDAMED	IVD General	Active
MutaPLEX® Norovirus, PCR	KG190196	EUDAMED	IVD General	Active
IDK® TurbiCAL®	TU1021.8	EUDAMED	IVD General	Active
Intact Proinsulin ELISA	K 7821	EUDAMED	IVD General	Active
Zinc-Protoporphyrin HPLC	KC2700	EUDAMED	IVD General	Active
IDK® α1-Antitrypsin ELISA	K 6750	EUDAMED	IVD General	Active
ID-Vit® Vitamin B12	KIF012.2	EUDAMED	IVD General	Active
ID-Vit® Niacin	KIF003.2	EUDAMED	IVD General	Active
IDK® Hemoglobin (human) ELISA	K 7816D.20	EUDAMED	IVD General	Active
MutaPlex® CoV-2 MUT 3, PCR	KG1933-384	EUDAMED	IVD General	Active
Idk® Mpo Elisa	K 6630	EUDAMED	IVD General	Active
IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA	K 7837D.20	EUDAMED	IVD General	Active
MutaPlex® SC2 multi gene, PCR	KG1930-768	EUDAMED	IVD General	Active
IDK® Calprotectin ELISA	K 6967	EUDAMED	IVD General	Active
MutaReal® PAI-1, PCR MutaPLATE PAI-1, PCR	KF291996	EUDAMED	IVD General	Active
MutaPLATE® GST-P1 (TM)	KF1903132	EUDAMED	IVD General	Active
IDK® Kynurenic Acid (KynA) ELISA	K 7735	EUDAMED	IVD General	Active
IDK® Helicobacter pylori Antigen ELISA	K 6923	EUDAMED	IVD General	Active
MutaREAL® Laktase	KF2907196	EUDAMED	IVD General	Active
Idk® Edn Elisa	K 6821	EUDAMED	IVD General	Active
Vdbp Elisa	K 2314	EUDAMED	IVD General	Active
MutaPLATE® VDR BsmI Real-Time-PCR-Kit	KF1900496	EUDAMED	IVD General	Active
anti-human tissue transglutaminase IgA (anti-htTG IgA) ELISA	K 9399	EUDAMED	IVD General	Active
MutaPLEX® Borrelia, PCR	KG1917096	EUDAMED	IVD General	Active
MutaPLEX® Blastocystis ST-1-3-4-7, PCR	KG192196	EUDAMED	IVD General	Active
IDK® Vitamin K1/K2 HPLC (SPE) Kit	KC2412	EUDAMED	IVD General	Active
QuantOn Cal®	KST11002EP04	EUDAMED	IVD General	Active
MutaPlex Borrelia/Rickettsia, PCR	KG194096	EUDAMED	IVD General	Active
IDK® anti-SARS-CoV-2 IgM ELISA	K 5001	EUDAMED	IVD General	Active
Homoarginin ELISA	K 7859	EUDAMED	IVD General	Active
MutaPLEX® Babesia, PCR	KG192496	EUDAMED	IVD General	Active
Carbonyl proteins (Serum, Plasma) ELISA	K 7870	EUDAMED	IVD General	Active
MutaPLEX® GastroSys4	KG1920-384	EUDAMED	IVD General	Active
MutaPLATE® Cystic Fibrosis	KF190832	EUDAMED	IVD General	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Immundiagnostik, Inc. Manchester, NH · US FEI 3015189693