FDA Registration
Active
🇩🇪 Germany
MassCheck® Total Metanephrines Urine Controls, Level I and Level II
Reg #: 3003951180
·
FEI: 3003951180
·
Expires 2025
Products
1
Proprietary Names
9
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 |
|---|---|---|---|---|---|
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2019-03-12 |
Proprietary Names
MassCheck® Total Metanephrines Urine Controls, Level I and Level II
MassCheck® VMA, HVA, 5-HIAA Urine Controls, Level I and Level II
t,t-Muconic Acid Urine Controls, Bi-Level, Level I and Level II
1-Hydroxypyrene Urine Controls, Bi-Level, Level I and Level II
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
Porphyrins Urine Controls, Bi-Level, Level I and Level II
Endocrine Urine Control, Normal and Pathological Range
Occupational Medicine Urine Controls, Bi-Level, Level I and Level II
Establishment Types
Manufacture Medical Device