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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 (397)

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Device	Model / Reference	Registries	Class	Status
anti-human tissue transglutaminase sIgA (anti-htTG sIgA) ELISA	K 9393	EUDAMED	IVD General	Active
total sRANKL ELISA	K 1016	EUDAMED	IVD General	Active
MutaPLEX® EU/BAC/BIF, PCR	KG1912-96	EUDAMED	IVD General	Active
MutaPLEX® FSME, PCR	KG1916032	EUDAMED	IVD General	Active
MutaREAL® ACE	KF290096	EUDAMED	IVD General	Active
MutaPLEX® Norovirus, PCR	KG190132	EUDAMED	IVD General	Active
β-Defensin 2 ELISA	K 6500	EUDAMED	IVD General	Active
Diaminooxidase (DAO) (3H-Nuclid) REA	K 8220	EUDAMED	IVD General	Active
ID-Vit® Vitamin B2	KIF002S	EUDAMED	IVD General	Active
IDK® Kynurenine ELISA	K 7728	EUDAMED	IVD General	Active
MutaPLEX® Borrelia, PCR	KG1917032	EUDAMED	IVD General	Active
anti-human epidermal transglutaminase IgA (anti-heTG IgA) ELISA	K 9396	EUDAMED	IVD General	Active
IDK® TurbiPEL®	TU1011.2	EUDAMED	IVD General	Active
PreventID® Dermatophyte	KSTDE001GP	EUDAMED	IVD General	Active
Nitrotyrosine (EDTA Plasma, Serum, Dried Blood) ELISA	K 7829.20	EUDAMED	IVD General	Active
IDKmonitor® Adalimumab drug level ELISA	K 9657	EUDAMED	IVD General	Active
PreventID® SARS-CoV-2 Antigen	KST90104GP	EUDAMED	IVD General	Active
Idk® Dao Elisa	K 8500	EUDAMED	IVD General	Active
MutaREAL® UGT1A1 Real-Time-PCR-Kit	KF091832	EUDAMED	IVD General	Active
ID-Vit® Folic acid	KIF005.2	EUDAMED	IVD General	Active
IDK® Vitamin K1/K2 HPLC Kit	KC2402	EUDAMED	IVD General	Active
IDK® PMN-Elastase ELISA	K 6841	EUDAMED	IVD General	Active
ID-Vit® Vitamin B2	KIF002S.2	EUDAMED	IVD General	Active
MutaPlex® RespiraScreen 2 DIFF, PCR	KG1928-768	EUDAMED	IVD General	Active
MutaPLATE® ACE	KF190096	EUDAMED	IVD General	Active
IDKmonitor® Infliximab total ADA	K 9654.20	EUDAMED	IVD General	Active
MutaPLEX® MTB/NTM/MAC	KG190832	EUDAMED	IVD General	Active
MutaPlex® Coronavirus 4G, PCR	KG1936-768	EUDAMED	IVD General	Active
IDK® Calprotectin ELISA	K 6928	EUDAMED	IVD General	Active
IDKmonitor® Adalimumab total ADA ELISA	K 9651	EUDAMED	IVD General	Active
MutaPLEX® Legionella spp., PCR	KG191932	EUDAMED	IVD General	Active
anti ox-LDL ELISA	K 7809	EUDAMED	IVD General	Active
MutaPLEX MRSA seqc, PCR	KG194196	EUDAMED	IVD General	Active
Adiponectin (total) ELISA	K 6250	EUDAMED	IVD General	Active
L-Citrullin	K 6600	EUDAMED	IVD General	Active
MutaREAL® HFE	KF291032	EUDAMED	IVD General	Active
β2-Mikroglobulin ELISA	K 6210	EUDAMED	IVD General	Active
IDK® Diaminooxidase (DAO) (1-Punkt-Kalibrierung) ELISA	K 8510	EUDAMED	IVD General	Active
IDK® Bile Acids	K 7878W	EUDAMED	IVD General	Active
Gaba Elisa	K 7009	EUDAMED	IVD General	Active
MutaREAL® MTHFR C677T	KF291432-A	EUDAMED	IVD General	Active
PreventID® CC	KST40110TP	EUDAMED	IVD General	Active
Retinol-bindendes Protein RBP/RBP4 ELISA	K 6110	EUDAMED	IVD General	Active
ID-Vit® Folic acid	KIF005	EUDAMED	IVD General	Active
MutaPLATE® MTHFR™	KF1901496	EUDAMED	IVD General	Active
IDK® TurbiCAL®	TU1021.2	EUDAMED	IVD General	Active
IDK® TNFα (Tumor Necrosis Factor alpha) ELISA	K 9610	EUDAMED	IVD General	Active
IDK® TurbiCAL®	TU1021.1	EUDAMED	IVD General	Active
Pregnenolonsulfat LC-MS/MS Kit	KM2000	EUDAMED	IVD General	Active
MutaPlex® RespiraScreen 1, PCR	KG192796	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