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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 (430)

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Device	Model / Reference	Registries	Class	Status
IDK TREx®	K 6993	EUDAMED	Class A	Active
SendNTest® Urine	KST99990GS02.01	EUDAMED	Class A	Active
SciconTest C-reaktives Protein hochsensitiv (CRP hs), Vitamin D (Vitamin D 25 OH), Nitrotyrosin und Serotonin	DZ9027SCSET	EUDAMED	Class A	Active
Tuning solution for the derivatized analyte	KM1002TU	EUDAMED	Class A	Active
Pregnenolone sulfate Control Set	YM2000CTRL1-3	EUDAMED	Class B	Active
DrySpot-ID®: dry blood carrier (4 Spots)	DZ9020CS	EUDAMED	Class A	Active
Transport medium for PCR swabs, tubes. 25 Itr	DZ8025	EUDAMED	Class A	Active
Tuning solution for the analyte	KM2000TU	EUDAMED	Class A	Active
DrySpot-ID®: dry blood carrier (6 Spots)	DZ9026NE	EUDAMED	Class A	Active
IDKhighX® stool preparation system – prefilled	K 6997XHP	EUDAMED	Class A	Active
MutaCLEAN Virus	KG1025-96	EUDAMED	Class A	Active
UPLC column	KM1002SP	EUDAMED	Class A	Active
1, 25-(OH)2-Vitamin D3/D2 ImmuTube® LC-MS/MS	YM1000	EUDAMED	Class B	Active
OmicSnap® NATcp (prefilled)	KV10023SET	EUDAMED	Class A	Active
Wash plate	KM1120WASHPLATE	EUDAMED	Class A	Active
1, 25-(OH)2-Vitamin D3/D2 Control Set	YM1000CTRL1-3	EUDAMED	Class B	Active
Hepcidin-25 LC-MS/MS Kit	KM4000	EUDAMED	Class B	Active
PreventID® Vital-D	KST80101EP13	EUDAMED	Class A	Active
IDKhighX® stool preparaion system - prefilled Set	K 6997XHPSET	EUDAMED	Class A	Active
SciconTest Carrier for dried blood	DZ9027SC	EUDAMED	Class A	Active
Stool sample preparation system filled with extraction buffer IDK Extract® (dilution 1:100)	K 6995	EUDAMED	Class A	Active
DrySpot-ID®: dry stool carrier (2 spots)	DZ9051ID	EUDAMED	Class A	Active
MutaCLEAN® Mag RNA/DNA	KG1024	EUDAMED	Class A	Active
1, 25-(OH)2-Vitamin D3/D2 IDKenhance® ImmuPlate® DIY LC-MS/MS	YM1022	EUDAMED	Class B	Active
96-well solid phase extraction plate	KM400096SPE	EUDAMED	Class A	Active
1, 25-(OH)2-Vitamin D3/D2 IDKenhance® ImmuTube® LC-MS/MS	YM1002	EUDAMED	Class B	Active
PreventID® Histaminintoleranz	KST70100EP	EUDAMED	Class A	Active
Stool sample preparation system filled with extraction buffer IDK Extract® (dilution 1:100)	K 6999SET	EUDAMED	Class A	Active
DrySpot-ID®: dry blood carrier (4 Spots)	DZ9020KI	EUDAMED	Class A	Active
Tuning solution for the internal standard	KM1000TS	EUDAMED	Class A	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