# BIODYNE

FEI: 3011496777
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Biodyne (#10047880)

Address: 24-4 Achasan-ro,  5-gil, Seongdong-gu, Seoul, 04793, KR

Mandatory US Agent: HSchem America

## Products

Total registered: 1
Top product codes: LDZ
Regulation §: 864.4010

Proprietary names: Cellprep Respiratory Tract Solution, Cellprep Urine-CSF Solution, Cellprep Gyn Lysis Solution, Cellprep Cervical Oral Solution, Cellprep Non-Gyn Lysis Solution, Cellprep Body Fluid-FNA Solution, Cellprep Urine direct Solution, Cellprep Urine Bottle, Cellprep Dilute Solution

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223011496777%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3011496777