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Chromsystems Instruments & Chemicals GmbH

US

Last updated May 23, 2026

What Chromsystems Instruments & Chemicals GmbH makes

Chromsystems Instruments & Chemicals GmbH produces in vitro diagnostic (IVD) reagents, kits, calibrators, and controls for liquid chromatography analysis, including high-performance chromatography columns. Their portfolio covers biogenic amine neurotransmitter testing (e.g., HVA, VMA, 5HIAA) and therapeutic drug monitoring controls for anticonvulsants and multi-therapy regimens. Microplate-based IVD solutions and urine/plasma/serum controls are also part of their offerings.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in clinical laboratories and diagnostic settings, adhering to relevant regulatory standards for IVD performance and safety.

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

Frequently asked questions

What types of medical devices does Chromsystems Instruments & Chemicals GmbH manufacture?

Chromsystems Instruments & Chemicals GmbH specializes in in vitro diagnostic (IVD) devices primarily used for liquid chromatography analysis. Their portfolio includes high-performance liquid chromatography analyser columns, reagents, kits, calibrators, and controls for biogenic amine neurotransmitter testing (such as HVA, VMA, and 5HIAA) as well as therapeutic drug monitoring controls for anticonvulsants and multi-therapy regimens. They also produce microplate-based IVD solutions and controls for urine, plasma, and serum samples, all designed for clinical laboratory and diagnostic use.

Where is Chromsystems Instruments & Chemicals GmbH based?

Chromsystems Instruments & Chemicals GmbH is based in the United States. While the company’s headquarters or primary operational location isn’t specified, their devices are regulated under U.S. FDA guidelines, indicating their market focus and compliance framework.

Which regulatory registries list Chromsystems Instruments & Chemicals GmbH’s devices?

Chromsystems Instruments & Chemicals GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for their Class I and Class II IVD products, which are intended for clinical and diagnostic applications. The UDI system helps track and verify device details for regulatory and quality purposes.

How are Chromsystems Instruments & Chemicals GmbH’s devices classified under FDA regulations?

Chromsystems Instruments & Chemicals GmbH’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in FDA’s regulatory framework for IVDs.

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

Information

Country
US
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Catalogue (590)

Page 5 of 12
DeviceModel / ReferenceRegistriesClassStatus
Plasma Calibration Standard 65003
FDA UDI
Class IIActive
Reagent Kit 2020-B
FDA UDI
Class IActive
Reagent Kit 5000
FDA UDI
Class IActive
Reagent 6006
FDA UDI
Class IActive
Reagent 51303/B
FDA UDI
Class IActive
Precolumn Cartridge 19034
FDA UDI
Class IActive
Whole Blood Calibration Standard 66003
FDA UDI
Class IIActive
Precolumn Cartridge 17037
FDA UDI
Class IActive
Whole Blood Control 0023
FDA UDI
Class IActive
Urine Calibration Standard 47003
FDA UDI
Class IIActive
Plasma Control 0332
FDA UDI
Class IActive
Plasma Control 0075
FDA UDI
Class IActive
Accessorie 6007
FDA UDI
Class IActive
Plasma Control 0043
FDA UDI
Class IActive
HPLC Column 47100
FDA UDI
Class IActive
Reagent 5031
EUDAMEDFDA UDI
Class IActive
Plasma Control 0132
FDA UDI
Class IActive
Plasma Control 0052
FDA UDI
Class IActive
HPLC Column 39100
FDA UDI
Class IActive
Plasma Control Bi-Level 0091
FDA UDI
Class IActive
Serum Control 0223
FDA UDI
Class IActive
Urine Control 0476
FDA UDI
Class IActive
Precolumn Cartridge 18067
FDA UDI
Class IActive
Reagent 81005
FDA UDI
Class IActive
Whole Blood Control 0273
FDA UDI
Class IActive
Urine Calibration Standard 6009
FDA UDI
Class IIActive
Plasma Control Bi-Level 0071
FDA UDI
Class IActive
Plasma Calibration Standard 25005
FDA UDI
Class IIActive
Serum Control Bi-Level 0064
FDA UDI
Class IActive
Plasma Control 0039
FDA UDI
Class IActive
Reagent 6055
FDA UDI
Class IActive
Plasma Control 0214/XT
FDA UDI
Class IActive
Urine Control 0475
FDA UDI
Class IActive
Accessorie 80059
FDA UDI
Class IActive
Serum Calibrator Set 72039
FDA UDI
Class IIActive
Reagent 80815
FDA UDI
Class IActive
Plasma Control Bi-Level 0213/XT
FDA UDI
Class IActive
Reagent Kit 6000
FDA UDI
Class IActive
Reagent 81006
FDA UDI
Class IActive
Plasma Calibration Standard 3009
FDA UDI
Class IIActive
Reagent Kit 80600/480
FDA UDI
Class IActive
Plasma Control 0242
FDA UDI
Class IActive
Dried Blood Control 0297
FDA UDI
Class IActive
Reagent 5001
FDA UDI
Class IActive
Accessorie 34758
FDA UDI
Class IActive
Trap Column 93122
FDA UDI
Class IActive
Reagent 6008/A9
FDA UDI
Class IActive
Reagent 80678
FDA UDI
Class IActive
Serum Control Bi-Level 0058
FDA UDI
Class IActive
Reagent 2026
FDA UDI
Class IActive

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FDA Establishments (1)

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

  • Chromsystems Instruments & Chemicals Gmbh Gräfelfing Bavaria · DE FEI 3003951180