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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 8 of 12
DeviceModel / ReferenceRegistriesClassStatus
Whole Blood Control Four Level 0081
FDA UDI
Class IActive
Urine Control Bi-Level 0045
FDA UDI
Class IActive
Urine Calibrator Set 96040
FDA UDI
Class IIActive
HPLC Column 54100
FDA UDI
Class IActive
Reagent Kit 65765/F
FDA UDI
Class IUnknown
Plasma Calibrator Set 64028
FDA UDI
Class IIActive
Plasma Control 0148
FDA UDI
Class IActive
Urine Control 0377
FDA UDI
Class IActive
Serum Control 0346
FDA UDI
Class IActive
Reagent 6010/COMBI
FDA UDI
Class IActive
Saliva Calibrator Set 73040
FDA UDI
Class IIActive
Urine Control 0381
FDA UDI
Class IActive
Urine Calibration Standard 53003
FDA UDI
Class IIActive
Plasma Calibrator Set 61028
FDA UDI
Class IIActive
Reagent 32004
FDA UDI
Class IActive
Serum Control 0026
FDA UDI
Class IActive
Whole Blood Calibration Standard 31003
FDA UDI
Class IIActive
Plasma Control 0215/XT
FDA UDI
Class IActive
Urine Calibration Standard 48003
FDA UDI
Class IIActive
Plasma Control 0473
FDA UDI
Class IActive
Reagent 34404
FDA UDI
Class IActive
Plasma Calibration Standard 49034
FDA UDI
Class IIActive
Urine Calibrator Set 64029
FDA UDI
Class IIActive
Plasma Control 0020
FDA UDI
Class IActive
Urine Control 0040
FDA UDI
Class IActive
Serum Calibrator Set 62039/CUSTOM/MAYO
FDA UDI
Class IIActive
Calibration Standard 3003
FDA UDI
Class IIActive
Reagent 1044/B/A1
FDA UDI
Class IActive
Reagent 5004
FDA UDI
Class IActive
Reagent 2025/A5
FDA UDI
Class IActive
Urine Control Bi-Level 0144
FDA UDI
Class IActive
Urine Control 0050
FDA UDI
Class IActive
Plasma Control 0055
FDA UDI
Class IUnknown
Reagent Kit 81000/C
FDA UDI
Class IActive
Reagent 6008/A1
FDA UDI
Class IActive
Serum Control 0312
FDA UDI
Class IActive
Plasma Control 0093
FDA UDI
Class IActive
Reagent 65001
FDA UDI
Class IActive
Reagent 1044/B/A5
FDA UDI
Class IActive
Tube 48010
FDA UDI
Class IActive
Reagent 44005
FDA UDI
Class IActive
Reagent 51005
FDA UDI
Class IActive
Reagent Kit 80600/96
FDA UDI
Class IActive
Urine Calibration Standard 2009
FDA UDI
Class IIActive
Serum Control 0341
FDA UDI
Class IActive
Plasma Control Bi-Level 0246
FDA UDI
Class IActive
Reagent 44002
FDA UDI
Class IActive
Analytical Column 62130
FDA UDI
Class IActive
Serum Calibration Standard 28005
FDA UDI
Class IIActive
Plasma Control 0232/XT
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