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
- [email protected]
- Phone
- 910 2289391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | CDA | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2007-12-06 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2007-12-06 |
| Enzyme Immunoassay, Tracrolimus | MLM | Class 2 | Clinical Chemistry | No | 2007-12-06 |
| Alcohol Control Materials | DKC | Class 1 | Clinical Toxicology | No | 2019-03-11 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2019-03-12 |
| Fluorometric Measurement, Porphyrins | JKJ | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2025-07-08 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2019-03-06 |
| Chromatographic/Fluorometric Method, Catecholamines | CHQ | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2019-11-22 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2019-03-12 |
| Chromatography (Liquid, Gel), Clinical Use | KZR | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Acid, Trifluoroacetic, Vitamin A, Hexane Extraction | JOA | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | CDF | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2019-02-28 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Detectors, Electrochemical, Liquid Chromatography | LEQ | Class 1 | Clinical Chemistry | No | 2004-10-28 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2019-03-11 |
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