FDA Registration
Active
🇩🇪 Germany
Vitamins A and E Serum Controls, Bi-Level, Level I and Level II
Reg #: 3003951180
·
FEI: 3003951180
·
Expires 2025
Products
1
Proprietary Names
21
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 |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2019-02-28 |
Proprietary Names
Vitamins A and E Serum Controls, Bi-Level, Level I and Level II
Antibiotics Plasma Controls, 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
Vitamin B6 Plasma Controls, Bi-Level, Level I and Level II
MassCheck® Steroid Panel 1 Serum Controls, Level I, Level II and Level III
Vitamins B1/B6 Whole Blood Controls, Bi-Level, Level I and Level II
Endocrine Plasma Controls, Normal and Pathological Range
MassCheck® Steroid Panel 2 Serum Controls, Level I, Level II and Level III
Crosslinks Urine Controls, Bi-Level, Level I and Level II
Benzodiazepines Plasma Controls, Bi-Level, Level I and Level II
MassCheck® Steroid Panel 1 & 2 Serum Controls, Level I, Level II and Level III
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
25-OH-Vitamin D3/D2 Serum Controls, Bi-Level, Level I and Level II
MassCheck® 25-OH-Vitamin D3/D2 Serum Controls, Bi-Level, Level I, Level II and Level III
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi 25-OH-Vitamin D3 Serum Controls, Bi-Level, Level I and Level II
MassCheck® Cortisol, Cortisone Saliva Controls, Level I and Level II
MassCheck Vitamins B1 and B6 Whole Blood Control Level I, Level II and Level III
MassCheck® Amino Acid Analysis Plasma Control, Level I, Level II and Level III
MassCheck® Amino Acid Analysis Urine Control, Level I, Level II and Level III
Establishment Types
Manufacture Medical Device