# FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)

FEI: 3003419906
Status: Active
Establishment types: Develop Specifications But Do Not Manufacture At This Facility
Owner/operator: FUJIFILM Wako Pure Chemical Corporation (#8030234)

Address: 6-1 Takata-cho, Amagasaki-shi Hyogo, 661-0963, JP

Mandatory US Agent: FUJIFILM Healthcare Americas Corporation

## Products

Total registered: 5
Top product codes: JJX, OAU, NSF, OUE, JIT
Regulation §: 862.1660, 866.6030, 862.2570, 862.1150

Proprietary names: uTASWako AFP-L3 Control L and H, uTASWako i30 Immunoanalyzer System, uTASWako DCP Control L and H, uTASWako AFP-L3 Calibrator Set, uTASWako AFP-L3 Sample Dilution Buffer, uTASWako AFP-L3 Immunological Test System, uTASWako DCP Calibrator Set, uTASWako DCP Immunological Test System, uTASWako Chip Cassette, uTASWako Wash Solution

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223003419906%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3003419906