# ROCHE DIAGNOSTICS GMBH

FEI: 3002806560
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Roche Diagnostics Operations Inc. (#9039767)

Address: NONNENWALD 2, PENZBERG Bavaria, D-82377, DE

Mandatory US Agent: Roche Diagnostics Operations Inc

## Products

Total registered: 1
Top product codes: NJT
Regulation §: 864.1860

Proprietary names: VENTANA TROP2 (EPR20043) Rabbit Monoclonal Antibody, Special Stains Congo Red Stain Core Kit, VENTANA MTAP (SP530) Rabbit Monoclonal Antibody, VENTANA MTAP (SP530) Antibody, anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody, CONFIRM anti-Cytokeratin (AE1) Primary Antibody, CONFIRM anti-Vimentin (V9) Primary Antibody, VENTANA iView DAB Universal Kit (export), CONFIRM anti-CD68 (KP-1) Primary Antibody, CONFIRM anti-MITF (C5/D5) Mouse Monoclonal Primary Antibody

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223002806560%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3002806560