FDA Registration Active 🇩🇪 Germany

Vitamins B1/B2 Whole Blood Calibration Standard

Reg #: 3003951180 · FEI: 3003951180 · Expires 2025
Products
1
Proprietary Names
56
Establishment Types
1
Classifications
1

Registration Details

Registration Name
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
Registration Number
3003951180
FEI Number
3003951180
Status
Active
Expiry Year
2025
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
Calibrator, Multi-Analyte Mixture JIX

Proprietary Names

Vitamins B1/B2 Whole Blood Calibration Standard Trileptal®, Zonisamide Serum Calibration Standard MassTox® Antiarrhythmic Drugs 3PLUS1® Multilevel Plasma Calibrator Set Perazine, Quetiapine, Citalopram Plasma Calibration Standard MassChrom® Cortisol, Cortisone 6PLUS1® Multilevel Saliva Calibrator Set Vitamin B6 Plasma Calibration Standard Catecholamines Calibration Standard and Urine Calibration Standard Vitamins B1/B6 Whole Blood Calibration Standard MassTox® Anti-HIV Drugs 6PLUS1® Multilevel Plasma Calibrator Set o-Cresol, p-Cresol, Phenol Urine Calibration Standard MassTox® Antimycotic Drugs / Extended 3PLUS1® Multilevel Plasma Calibrator Set MassChrom® Steroid Panel 2 6PLUS1® Multilevel Serum Calibrator Set MassChrom® 25-OH-Vitamin D3/D2 3PLUS1® Multilevel Serum Calibrator Set and 6PLUS1® Multilevel Serum Calibrator Set MassTox® Benzodiazepines 1 3PLUS1® Multilevel Plasma Calibrator Set Extended Benzodiazepines Plasma Calibration Standard MassTox® Immunosuppresants 6PLUS1® Multilevel Whole Blood Calibrator Set 25-OH-Vitamin D3/D2 Serum Calibration Standard Rufinamide, Felbamate, Lacosamide Serum Calibration Standard Metanephrines Urine Calibration Standard and Calibration Standard Crosslinks Urine Calibration Standard Olanzapine, Desmethylolanzapine Plasma Calibration Standard Mycophenolic Acid/Glucuronide 3PLUS1® and 6PLUS1® Multilevel Plasma Calibrator Set and MPA Plasma Calibration Standard Porphyrins Urine Calibration Standard Antiepileptic Drugs, Serum Calibration Standards MassTox® Tricyclic Antidepressants TCA 1 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Benzodiazepines 2 3PLUS1® Multilevel Plasma Calibrator Set Antibiotics Plasma Calibration Standard and 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Neuroleptics 2/ EXTENDED2 3PLUS1® Multilevel Plasma Calibrator Set 6PLUS1 Multilevel Whole Blood Calibrator Set MassChrom Vitamins B1 and B6 VMA, HVA, 5-HIAA Calibration Standard and Urine Calibration Standard Occupational Medicine Urine Calibration Standard Clobazam, Norclobazam Plasma Calibration Standard MassTox® Antidepressants 2/ Psychostimulants/EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set 3PLUS1 Multilevel Plasma Calibrator Set MassChrom Amino Acid Analysis in plasma/serum Pregabalin, Vigabatrin, Gabapentin Serum Calibration Standard MassChrom® Steroid Panel 1 and Panel 2 6PLUS1® Multilevel Serum Calibrator Set Sultiame, Lamotrigine Serum Calibration Standard Vitamins A and E Serum Calibration Standard MassChrom® Total Metanephrines 6PLUS1® Multilevel Urine Calibrator Set MassTox® Antidepressants 1/EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set MassChrom® Steroid Panel 1 6PLUS1® Multilevel Serum Calibrator Set MassChrom® Free Metanephrines 6PLUS1® Multilevel Plasma Calibrator Set MassTox® Neuroleptics 2/ EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set Imatinib, Dasatinib, Nilotinib 3PLUS1® Multilevel Plasma Calibrator Set Vitamin B6 Whole Blood Calibration Standard Itraconazole, Posaconazole, Voriconazole Plasma Calibration Standard and 3PLUS1® Multilevel Plasma Calibrator Set MassChrom® Catecholamines, free Metanephrines, Serotonin 6PLUS1® Multilevel Urine Calibrator Set MassTox® Tricyclic Antidepressants TCA 2 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Antiepileptic Drugs/EXTENDED 3PLUS1® Multilevel Plasma Calibrator Set Catecholamines Plasma Calibration Standard, and Calibration Standard t,t-Muconic Acid Urine Calibration Standard Benzodiazepines Plasma Calibration Standard Alprazolam, Trazodone Plasma Calibration Standard MassChrom® VMA, HVA, 5-HIAA 6PLUS1® Multilevel Urine Calibrator Set MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 3PLUS1® Multilevel Serum Calibrator Set 3PLUS1 Multilevel Plasma Calibrator Set MassChrom Amino Acid Analysis in urine

Establishment Types

Manufacture Medical Device