FDA Registration Active 🇩🇪 Germany

Dimension Vista C1IN Con

Reg #: 9610806 · FEI: 3001644026 · Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3

Registration Details

Registration Name
Siemens Healthcare Diagnostics Products GmbH
Registration Number
9610806
FEI Number
3001644026
Status
Active
Expiry Year
2025
Initial Importer
No
Address
76 EMIL-VON-BEHRING STRASSE
City
MARBURG Hesse
Country
DE

Regulatory Submissions

510(k) Number
K072965

Owner / Operator

Firm Name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Operator Number
9096044
Address
Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
City
Tarrytown
State
NY
Postal Code
10591
Country
US
Correspondent
Mary Seeger

Products

Device Name Product Code
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control DBA
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Calibrator, Secondary JIT

Proprietary Names

Dimension Vista C1IN Con Dimension Vista C1IN Flex Dimension Vista C1IN Cal

Establishment Types

Manufacture Medical Device