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FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)

FEI 3003419906 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active

FEI Number3003419906
Owner / OperatorFUJIFILM Wako Pure Chemical Corporation (#8030234)
Address6-1 Takata-cho, Amagasaki-shi Hyogo, 661-0963, JP
Mandatory US AgentFUJIFILM Healthcare Americas Corporation
Registration expiry2026
Initial importer flagN
Registered products5
Product codes (top 20)JJX, OAU, NSF, OUE, JIT
Regulation § (21 CFR)862.1660, 866.6030, 862.2570, 862.1150
Proprietary namesuTASWako 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

External sources

Source: openFDA. Public-domain (CC0).