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
Phone
910 2289391

Products

Device Name Product Code
Multi-Analyte Controls, All Kinds (Assayed) JJY

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