FDA Registration Active 🇩🇪 Germany

CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

Reg #: 3003951180 · FEI: 3003951180 · Expires 2026
Products
19
Proprietary Names
183
Establishment Types
3
Classifications
19

Registration Details

Registration Name
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
Registration Number
3003951180
FEI Number
3003951180
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Am Haag 12
City
Gräfelfing Bavaria
Country
DE

Owner / Operator

Firm Name
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
Operator Number
9067715
Address
Am Haag 12, --
City
Graefelfing
State
DE-NOTA
Postal Code
82166
Country
DE

US Agent

Business Name
confinis USA Inc.
Contact Name
Alfred Lerch
Address
600 Park Offices Drive Suite 300, Unit #50
City
Durham
State
NC
ZIP
27709
Country
US
Phone
910 2289391

Products

Device Name Product Code
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin CDA
Calibrator, Secondary JIT
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Enzyme Immunoassay, Tracrolimus MLM
Alcohol Control Materials DKC
Urinalysis Controls (Assayed And Unassayed) JJW
Fluorometric Measurement, Porphyrins JKJ
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Calibrator, Multi-Analyte Mixture JIX
Chromatographic/Fluorometric Method, Catecholamines CHQ
Calibrators, Drug Specific DLJ
Calibrators, Ethyl Alcohol DNN
Chromatography (Liquid, Gel), Clinical Use KZR
Acid, Trifluoroacetic, Vitamin A, Hexane Extraction JOA
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin CDF
Multi-Analyte Controls, All Kinds (Assayed) JJY
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
Detectors, Electrochemical, Liquid Chromatography LEQ
Drug Specific Control Materials LAS

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 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 CHROMSYSTEMS PUMP AUTOSAMPLER Restrictor Capillary Precolumn Cartridge Master Column Trap Column Analytical Column HPLC Column DETECTORS COLUMNS Vitamins A & E by HPLC Test HPLC Reagent Kit beta carotene in serum/plasma UHPLC Reagent Kit One Step Vitamins A and E in serum/plasma UHPLC Reagent Kit Vitamins A and E in serum/plasma Automated with 96 Well Filter Plates HPLC Reagent Kit Vitamins A and E in serum/plasma HPLC Reagent Kit One Step Vitamins And E in serum/plasma HPLC Reagent Kit Vitamins A and E in serum/plasma Automated with 96 Well Filter Plates VMA, HVA, 5-HIAA in Urine MassChrom Biogenic amines/Metabolites in Urine, VMA, HVA, 5-HIAA in Urine MassCheck® Steroid Panel 2 Serum Controls, Level I, Level II and Level III MassCheck® Steroid Panel 1 Serum Controls, Level I, Level II and Level III Benzodiazepines Plasma Controls, Bi-Level, Level I and Level II 25-OH-Vitamin D3/D2 Serum Controls, Bi-Level, Level I and Level II MassCheck® Amino Acids, Acylcarnitines incl. Succinylacetone Dried Blood Spot Controls, Bi-Level, Level I and Level II Vitamin B6 Whole Blood Controls, Bi-Level, Level I and Level II Endocrine Plasma Controls, Normal and Pathological Range Vitamins A and E Serum Controls, Bi-Level, Level I and Level II Vitamin B6 Plasma Controls, Bi-Level, Level I and Level II MassCheck® Steroid Panel 1 & 2 Serum Controls, Level I, Level II and Level III Vitamins B1/B6 Whole Blood Controls, Bi-Level, Level I and Level II Crosslinks Urine Controls, Bi-Level, Level I and Level II MassCheck® Free Metanephrines Plasma Controls, Level I, Level II and Level III Vitamin B1/B2 Whole Blood Controls, Bi-Level, Level I and Level II MassCheck® Cortisol, Cortisone Saliva Controls, Level I and Level II MassCheck® 25-OH-Vitamin D3/D2 Serum Controls, Bi-Level, Level I, Level II and Level III Antibiotics Plasma Controls, Level I and Level II MassCheck® 25-OH-Vitamin D3/D2 and 3-epi 25-OH-Vitamin D3 Serum Controls, Bi-Level, Level I and Level II MassCheck Vitamins B1 and B6 Whole Blood Control Level I, Level II and Level III MassCheck® Amino Acid Analysis Urine Control, Level I, Level II and Level III MassCheck® Amino Acid Analysis Plasma Control, Level I, Level II and Level III MassCheck® Amino Acids, Acylcarnitines EXTENDED Dried Blood Spot Control Level I, II and III MassCheck® Amino Acids, Acylcarnitines EXTENDED incl. Ado, dAdo Dried Blood Spot Control Level I, II and III Vitamin C in Plasma/Serum ELECTROCHEMICAL DETECTOR CLC 100 Amiodarone, Desethylamiodarone Plasma Calibration Standard Levetiracetam Serum Calibration Standard Coenzyme Q10 Plasma Calibration Standard Vitamin C Plasma Calibration Standard Malondialdehyde Plasma Calibration Standard Homocysteine Plasma Calibration Standard beta-Carotene Serum Calibration Standard Serotonin Calibration Standard and Urine Calibration Standard 1-Hydroxypyrene Urine Calibration Standard Serotonin Plasma Calibration Standard and Calibration Standard MassChrom® Methylmalonic Acid 3PLUS1® Multilevel Plasma Calibrator Set and 3PLUS1® Multilevel Urine Calibrator Set Glutathione Whole Blood Calibration Standard Levetiracetam (Keppra®) Serum Controls, Bi-Level, Level I and Level II MassCheck® Mycophenolic Acid/Glucuronide Plasma Controls, Bi-Level, Level I and Level II Perazine, Quetiapine, Citalopram Plasma Controls, Bi-Level, Level I and Level II MassCheck® Antimycotic Drugs Plasma/EXTENDED Controls, Bi-Level, Level I and Level II Imatinib, Dasatinib, Nilotinib Plasma Controls, Bi-Level, Level I and Level II Itraconazole, Posaconazole, Voriconazole Plasma Controls, Tri-Level, Level I, Level II and Level III MassCheck® Antidepressants 2/ Psychostimulants/EXTENDED Plasma Controls, Bi-Level, Level I and Level II Pregabalin, Vigabatrin, Gabapentin Serum Controls, Bi-Level (I+II) Antiepileptic Drugs Serum Controls, Bi-Level, Tri-Level, Level I, Level II and Level III MassCheck® Benzodiazepines 2 Plasma Controls, Bi-Level, Level I and Level II Extended Benzodiazepines Plasma Controls, Bi-Level, Level I and Level II MassCheck® Benzodiazepines 1 Plasma Controls, Bi-Level, Level I and Level II MassCheck® Drugs of Abuse Testing Urine Hydrolysis Conrol Set MassCheck® Antiarrythmic Drugs Plasma Controls, Bi-Level, Level I and Level II MassCheck® Tricyclic Antidepressants TCA 2 Plasma Controls, Bi-Level, Level I and Level II Clobazam, Norclobazam Plasma Controls, Bi-Level (I+II) Olanzapine, Desmethylolanzapine Plasma Controls, Bi-Level, Level I and Level II MassCheck® Tricyclic Antidepressants TCA 1 Plasma Controls, Bi-Level, Level I and Level II Trileptal®, Zonisamide Serum Controls, Bi-Level (I+II) MassCheck® Anti-HIV Drugs Plasma Controls, Bi-Level, Level I and Level II MassCheck® Neuroleptics 2/EXTENDED Plasma Controls, Bi-Level, Level I and Level II Rufinamide, Felbamate, Lacosamide Serum Controls, Bi-Level (I+II) Mycophenolic Acid Plasma Controls, Bi-Level, Level I and Level II Sultiame, Lamotrigine Serum Controls, Bi-Level (I+II) MassCheck® Antiepileptic Drugs/EXTENDED Plasma Controls, Bi-Level, Level I and Level II MassCheck® Antidepressants 1/EXTENDED Plasma Controls, Bi-Level, Level I and Level II Alprazolam, Trazodone Plasma Controls, Bi-Level (I+II) Amiodarone, Desethylamiodarone Plasma Controls, Level I and Level II MassCheck® Immunosuppressants Whole Blood Controls, Four-Level, Level I, Level II, Level III, Level IV and Blank Control MassCheck® Drugs of Abuse Testing Urine Control Set Level III MassCheck® Neuroleptics 2/EXTENDED2 Plasma Controls, Bi-Level, Level I and Level II MassCheck® Drugs of Abuse Testing Urine Control Set Level I Urine Screening Standard Set MassTox® Drugs of Abuse Testing in urine MassCheck® Drugs of Abuse Testing Urine Control Set Level II MassCheck® Antiepileptic Drugs XT2 Plasma Controls, Bi-Level, Level I and Level II

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device