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
- [email protected]
- Phone
- 910 2289391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2019-03-06 |
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