CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

FDA Device Registration & Listing · Gräfelfing Bavaria, DE · Registration 3003951180

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003951180
FEI Number
3003951180
Entity Name
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
City/State/Country
Gräfelfing Bavaria, DE
Establishment Address
Am Haag 12, Gräfelfing Bavaria 82166, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH (Owner Number: 9067715)
Owner / Operator Contact Address
Am Haag 12, --, Graefelfing, DE-NOTA 82166, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MassChrom Biogenic amines/Metabolites in Urine, Catecholamines, free Metanephrines, Serotonin Serotonin in Serum/Plasma/Whole Blood Serotonin in Urine 5-Hydroxyindoleacetic acid in Urine MassTrak MassCheck® Methylmalonic Acid Urine Controls, Bi-Level, Level I and Level II Glutathione Whole Blood Controls, Bi-Level, Level I and Level II Vitamin C Plasma Controls, Bi-Level, Level I and Level II ?-Carotene Serum Controls, Bi-Level, Level I and Level II MassCheck® Methylmalonic Acid Plasma Controls, Bi-Level, Level I and Level II Coenzyme Q10 Plasma Controls, Bi-Level, Level I and Level II Homocysteine Plasma Controls, Bi-Level, Level I and Level II Malondialdehyde Plasma Controls, Bi-Level, Level I and Level II CDT Serum Controls, Level I and Level II MassCheck® Ethyl Glucuronide, Ethyl Sulfate Urine Controls, Level I, Level II and Level III o-Cresol, p-Cresol, Phenol Urine Controls, Bi-Level, Level I and Level II MassCheck® Catecholamines, free Metanephrines, Serotonin Urine Controls, Level I and Level II t,t-Muconic Acid Urine Controls, Bi-Level, Level I and Level II MassCheck® Total Metanephrines Urine Controls, Level I and Level II MassCheck® VMA, HVA, 5-HIAA Urine Controls, Level I and Level II Porphyrins Urine Controls, Bi-Level, Level I and Level II 1-Hydroxypyrene Urine Controls, Bi-Level, Level I and Level II Occupational Medicine Urine Controls, Bi-Level, Level I and Level II Endocrine Urine Control, Normal and Pathological Range PORPHYRINS BY HPLC TEST PEEK-encased Prefilter 0.5 µm 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Antiepileptic Drugs XT2 Sultiame, Lamotrigine Serum Calibration Standard MassTox® Antidepressants 2/ Psychostimulants/EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set Crosslinks Urine Calibration Standard Olanzapine, Desmethylolanzapine Plasma Calibration Standard MassTox® Immunosuppresants 6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Neuroleptics 2/ EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set Clobazam, Norclobazam Plasma Calibration Standard MassChrom® Steroid Panel 1 6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 1 and Panel 2 6PLUS1® Multilevel Serum Calibrator Set MassChrom® Total Metanephrines 6PLUS1® Multilevel Urine Calibrator Set Trileptal®, Zonisamide Serum Calibration Standard Extended Benzodiazepines Plasma Calibration Standard MassChrom® Cortisol, Cortisone 6PLUS1® Multilevel Saliva Calibrator Set Vitamins B1/B2 Whole Blood Calibration Standard Perazine, Quetiapine, Citalopram Plasma Calibration Standard MassChrom® VMA, HVA, 5-HIAA 6PLUS1® Multilevel Urine Calibrator Set Mycophenolic Acid/Glucuronide 3PLUS1® and 6PLUS1® Multilevel Plasma Calibrator Set and MPA Plasma Calibration Standard MassTox® Antiepileptic Drugs/EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set Antiepileptic Drugs, Serum Calibration Standards MassTox® Benzodiazepines 2 3PLUS1® Multilevel Plasma Calibrator Set Vitamins A and E Serum Calibration Standard Vitamins B1/B6 Whole Blood Calibration Standard MassChrom® Free Metanephrines 6PLUS1® Multilevel Plasma Calibrator Set Imatinib, Dasatinib, Nilotinib 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Tricyclic Antidepressants TCA 2 3PLUS1® Multilevel Plasma Calibrator Set Vitamin B6 Whole Blood Calibration Standard MassTox® Tricyclic Antidepressants TCA 1 3PLUS1® Multilevel Plasma Calibrator Set Antibiotics Plasma Calibration Standard and 3PLUS1® Multilevel Plasma Calibrator Set MassChrom® Catecholamines, free Metanephrines, Serotonin 6PLUS1® Multilevel Urine Calibrator Set MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 3PLUS1® Multilevel Serum Calibrator Set MassTox® Antiarrhythmic Drugs 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Antimycotic Drugs / Extended 3PLUS1® Multilevel Plasma Calibrator Set Alprazolam, Trazodone Plasma Calibration Standard o-Cresol, p-Cresol, Phenol Urine Calibration Standard 6PLUS1 Multilevel Whole Blood Calibrator Set MassChrom Vitamins B1 and B6 25-OH-Vitamin D3/D2 Serum Calibration Standard Rufinamide, Felbamate, Lacosamide Serum Calibration Standard MassTox® Benzodiazepines 1 3PLUS1® Multilevel Plasma Calibrator Set Pregabalin, Vigabatrin, Gabapentin Serum Calibration Standard Urine Calibration Standard Metanephrines in urine Porphyrins Urine Calibration Standard Vitamin B6 Plasma Calibration Standard MassTox® Antidepressants 1/EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set Calibration Standard VMA, HVA, 5-HIAA in urine Occupational Medicine Urine Calibration Standard MassChrom® 25-OH-Vitamin D3/D2 3PLUS1® Multilevel Serum Calibrator Set and 6PLUS1® Multilevel Serum Calibrator Set Itraconazole, Posaconazole, Voriconazole Plasma Calibration Standard and 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Anti-HIV Drugs 6PLUS1® Multilevel Plasma Calibrator Set Catecholamines Plasma Calibration Standard, and Calibration Standard t,t-Muconic Acid Urine Calibration Standard MassChrom® Steroid Panel 2 6PLUS1® Multilevel Serum Calibrator Set Urine Calibration Standard Catecholamines in urine Benzodiazepines Plasma Calibration Standard MassTox® Neuroleptics 2/ EXTENDED2 3PLUS1® Multilevel Plasma Calibrator Set 3PLUS1 Multilevel Plasma Calibrator Set MassChrom Amino Acid Analysis in plasma/serum 3PLUS1 Multilevel Plasma Calibrator Set MassChrom Amino Acid Analysis in urine MassChrom Biogenic amines/Metabolites in Urine, Catecholamines, free Metanephrines, Serotonin Catecholamines in Urine Catecholamines in Plasma Combined Analysis of Chatecholamines and Metanphrines in Urine MassChrom Biogenic amines/Metabolites in Urine, Total Metanphrines (free + conjugated) MassChrom Free Metanephrines in Plasma Metaneprhines in Urine Urien Screening Standard Set Mass Tox Drugs of Abuse Testing inurine 6PLUS1 Multilevel Urine Calibrator Set MassTox Drugs of Abuse Testing in urine MassChrom® Ethyl Glucuronide, Ethyl Sulfate 6PLUS1® Multilevel Urine Calibrator Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CDA Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin Clinical Chemistry Class 1 862.1390 2004-10-28
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2007-12-06
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-12-06
MLM Enzyme Immunoassay, Tracrolimus Clinical Chemistry Class 2 862.1678 2007-12-06
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2019-03-12
DKC Alcohol Control Materials Clinical Toxicology Class 1 862.3280 2019-03-11
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2019-03-12
JKJ Fluorometric Measurement, Porphyrins Clinical Chemistry Class 1 862.1595 2004-10-28
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2025-07-08
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2019-03-06
CHQ Chromatographic/Fluorometric Method, Catecholamines Clinical Chemistry Class 1 862.1165 2004-10-28
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2019-11-22
DNN Calibrators, Ethyl Alcohol Clinical Toxicology Class 2 862.3200 2019-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Alfred Lerch Business: confinis USA Inc. Email: usagent@confinis.com Phone: (910) 2289391

Related Public Records

Same Entity

CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21
K081789 Siemens Healthcare Diagnostics, Inc. DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR 2008-09-10
K103836 Siemens Healthcare Diagnostics, Inc. ENZYME II CALIBRATOR 2011-02-16
K103548 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 2011-06-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021 Siemens Healthcare Diagnostics, Inc. 2
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003951180. Last updated year: 2026. Please use registration number 3003951180 when referencing this establishment in official correspondence.
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