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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 11 of 12
DeviceModel / ReferenceRegistriesClassStatus
Plasma Control 0314
FDA UDI
Class IActive
Reagent Kit 2020
FDA UDI
Class IActive
Urine Control Bi-Level 0138
FDA UDI
Class IActive
Reagent 81015
FDA UDI
Class IActive
Serum Control Bi-Level 0025
FDA UDI
Class IActive
Serum Control 0060
FDA UDI
Class IActive
Plasma Control 0076
FDA UDI
Class IActive
Plasma Control 0212/XT
FDA UDI
Class IUnknown
Accessorie 80055
FDA UDI
Class IActive
HPLC Column 49100
FDA UDI
Class IActive
Trap Column 93110
FDA UDI
Class IActive
Basic Kit 2020-C-BK
FDA UDI
Class IActive
Plasma Control 0239
FDA UDI
Class IActive
Serum Control Bi-Level 0032
FDA UDI
Class IActive
Whole Blood Control Bi-Level 0077
FDA UDI
Class IActive
HPLC Column 51100
FDA UDI
Class IActive
Plasma Calibrator Set 92025/XT
FDA UDI
Class IIActive
Reagent 6004
FDA UDI
Class IActive
Urine Control Set 0420
FDA UDI
Class IActive
HPLC Column 15390
FDA UDI
Class IActive
Reagent 2021
FDA UDI
Class IActive
Reagent Kit 2020/A9
FDA UDI
Class IActive
Plasma Control 0266
FDA UDI
Class IActive
Plasma Calibration Standard 49033
FDA UDI
Class IIUnknown
Analytical Column 81100
FDA UDI
Class IActive
Serum Calibrator Set 72040
FDA UDI
Class IIActive
Reagent 34405
FDA UDI
Class IActive
Dried Blood Control 0296
FDA UDI
Class IActive
Plasma Control Bi-Level 0243
FDA UDI
Class IActive
Reagent Kit 34400-DWP
FDA UDI
Class IActive
Serum Control 0168
FDA UDI
Class IActive
Plasma Calibrator Set 92026/XT2
FDA UDI
Class IIActive
Reagent 80609
FDA UDI
Class IActive
Reagent 1006
FDA UDI
Class IActive
Urine Control 0143
FDA UDI
Class IActive
Reagent 80001
FDA UDI
Class IActive
HPLC Column 61100
FDA UDI
Class IActive
Plasma Control 0250-XT2
FDA UDI
Class IActive
Plasma Calibration Standard 36005
FDA UDI
Class IIActive
Serum Control 0180
FDA UDI
Class IActive
Plasma Calibrator Set 58028
FDA UDI
Class IIActive
HPLC Column 27110
FDA UDI
Class IActive
Urine Calibrator Set 96033
FDA UDI
Class IIActive
Reagent 51003
FDA UDI
Class IActive
Reagent Kit 34900/UHPLC
FDA UDI
Class IActive
Reagent 81010
FDA UDI
Class IActive
Reagent 32001
FDA UDI
Class IActive
Plasma Control 0149
FDA UDI
Class IActive
Precolumn Cartridge 17046
FDA UDI
Class IActive
Plasma Control Bi-Level 0252/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