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Sign in to claim this brandChromsystems 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 12 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dried Blood Control | 0295 | FDA UDI | Class I | Active |
| Whole Blood Calibrator Set | 28039 | FDA UDI | Class II | Active |
| Reagent | 2044/HR | FDA UDI | Class I | Active |
| Reagent | 80677 | FDA UDI | Class I | Active |
| Plasma Calibration Standard | 49035 | FDA UDI | Class II | Active |
| Reagent | 2026/A5 | FDA UDI | Class I | Active |
| Serum Control | 0088 | FDA UDI | Class I | Active |
| Plasma Control | 0183 | FDA UDI | Class I | Active |
| Whole Blood Control | 0275 | FDA UDI | Class I | Active |
| HPLC Column | 22100/HR | FDA UDI | Class I | Active |
| Plasma Control Bi-Level | 0041 | FDA UDI | Class I | Active |
| Urine Control Bi-Level | 0161 | FDA UDI | Class I | Active |
| Reagent | 5001/K | FDA UDI | Class I | Active |
| Accessorie | 81059 | FDA UDI | Class I | Active |
| Urine Control | 0373 | FDA UDI | Class I | Active |
| Plasma Calibrator Set | 92025-XT2 | FDA UDI | Class II | Active |
| Reagent | 4055 | FDA UDI | Class I | Active |
| Plasma Control Bi-Level | 0224 | FDA UDI | Class I | Active |
| Urine Control | 0317 | FDA UDI | Class I | Active |
| Reagent | 5011 | FDA UDI | Class I | Active |
| Accessorie | 81056 | FDA UDI | Class I | Active |
| Analytical Column | 96100 | FDA UDI | Class I | Active |
| Precolumn Cartridge | 18022/FHR | FDA UDI | Class I | Active |
| HPLC Column | 24100/HR | FDA UDI | Class I | Active |
| Plasma Control | 0231/XT | FDA UDI | Class I | Active |
| Plasma Calibrator Set | 92032 | FDA UDI | Class II | Active |
| Plasma Control Bi-Level | 0061 | FDA UDI | Class I | Active |
| Plasma Control Bi-Level | 0074 | FDA UDI | Class I | Active |
| Reagent Kit | 51000 | FDA UDI | Class I | Active |
| Plasma Control | 0472 | FDA UDI | Class I | Active |
| Serum Control | 0342 | FDA UDI | Class I | Active |
| Plasma Control | 0053 | FDA UDI | Class I | Active |
| Reagent | 44006 | FDA UDI | Class I | Active |
| Reagent | 80675 | FDA UDI | Class I | Active |
| Reagent Kit | 80800/480 | FDA UDI | Class I | Active |
| Precolumn Cartridge | 18065 | FDA UDI | Class I | Active |
| Reagent | 80805 | FDA UDI | Class I | Active |
| Urine Calibration Standard | 43003 | FDA UDI | Class II | Active |
| Reagent | 3034 | FDA UDI | Class I | Active |
| Chromesytems Toxicology Calibrators And Controls | K080459 | FDA 510(k) | Class I | Active |
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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