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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

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US
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Catalogue (590)

Page 4 of 12
DeviceModel / ReferenceRegistriesClassStatus
Reagent Kit 80600/C
FDA UDI
Class IActive
Reagent 44001
FDA UDI
Class IActive
HPLC Column 4100
FDA UDI
Class IActive
HPLC Column 31100
FDA UDI
Class IActive
Reagent 4006
FDA UDI
Class IActive
Plasma Control 0241
FDA UDI
Class IActive
Serum Calibration Standard 38033
FDA UDI
Class IIActive
HPLC Column 15490
FDA UDI
Class IActive
Reagent 2031/COMBI
FDA UDI
Class IActive
Serum Calibrator Set 62028
FDA UDI
Class IIActive
Whole Blood Control 0165
FDA UDI
Class IActive
Whole Blood Control Bi-Level 0022
FDA UDI
Class IActive
HPLC Column 53100
FDA UDI
Class IActive
Reagent Kit 2020/COMBI
FDA UDI
Class IActive
HPLC Column 34300
FDA UDI
Class IActive
Plasma Calibration Standard 39004
FDA UDI
Class IIActive
Urine Control 0142
FDA UDI
Class IActive
HPLC Column 2120
FDA UDI
Class IActive
Reagent 80679
FDA UDI
Class IActive
Serum Control 0339
FDA UDI
Class IActive
Plasma Control 0251-XT2
FDA UDI
Class IActive
Accessorie 4008
FDA UDI
Class IActive
Plasma Control Bi-Level 0031
FDA UDI
Class IActive
Plasma Calibration Standard 49003
FDA UDI
Class IIUnknown
Plasma Control 0385
FDA UDI
Class IActive
Reagent Kit 6000/COMBI
FDA UDI
Class IActive
Serum Control 0170
FDA UDI
Class IActive
Accessorie 80057
FDA UDI
Class IActive
Reagent 34708
FDA UDI
Class IActive
Plasma Control 0096
FDA UDI
Class IActive
Precolumn Cartridge 18061
FDA UDI
Class IActive
Plasma Control Bi-Level 0234
FDA UDI
Class IActive
Reagent Kit 3030
FDA UDI
Class IActive
Serum Control 0029
FDA UDI
Class IActive
Reagent 80606
FDA UDI
Class IActive
Plasma Control 0226
FDA UDI
Class IActive
Serum Calibration Standard 29004
FDA UDI
Class IIActive
Whole Blood Calibration Standard 37008
FDA UDI
Class IIActive
Plasma Calibrator Set 92027/XT
FDA UDI
Class IIActive
Reagent 34008
FDA UDI
Class IActive
Accessorie 2010
FDA UDI
Class IActive
Plasma Control 0235
FDA UDI
Class IActive
Accessorie 34456
FDA UDI
Class IActive
Reagent Kit 6000/A1
FDA UDI
Class IActive
Whole Blood Calibration Standard 87039
FDA UDI
Class IIActive
Urine Control 0046
FDA UDI
Class IActive
Plasma Control 0254/XT
FDA UDI
Class IActive
Reagent 1004/B
FDA UDI
Class IActive
Plasma Calibration Standard 46003
FDA UDI
Class IIActive
Urine Calibration Standard 1009
FDA UDI
Class IIActive

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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