Sysmex I N T Reagents Co L T D Ono Factory

FDA Filings

This page includes the latest FDA filings for Sysmex I N T Reagents Co L T D Ono Factory. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010188738
FEI Number3002808299
NameSysmex International Reagents Co., LTD ONO FACTORY
Owner & OperatorSYSMEX CORPORATION
Contact Address1-5-1 WAKINOHAMA-KAIGANDORI CHUO-KU
KOBE JP-28 Hyogo 651-0073 JP
Official Correspondent
  • JAIME - HOUGHTON
  • 81-7826-50500-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address17 Takumidai
Ono Hyogo, 675-1322 JP
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
URINOSEARCH2012-08-17
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UFII SEARCH-SED2012-08-17
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UFII SEARCH-BAC2012-08-17
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF-Fluorocell SF2012-08-17
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF-Fluorocell CR2012-08-17
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
STROMATOLYSER NR (S)2012-06-04
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
FLUOROCELL WPC2012-06-04
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
FLUOROCELL WNR2012-06-04
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
FLUOROCELL WDF2012-06-04
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
FLUOROCELL RET2012-06-04
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
FLUOROCELL PLT2012-06-04
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
pocH-pack D2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
XW pack D2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF-CELLSHEATH2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF-CELLPACK SF2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF-CELLPACK CR2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF II Sheath2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF II PACK-BAC2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
UF II PACK SED2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
RETSEARCH II2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Cellsheath2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Cellsheath C2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Cellpack2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CELLSHEATH CCS2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CELLPACK S2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CELLPACK DST2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CELLPACK DFL2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CELLPACK DCL2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
pocH-pack L2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
XW pack L2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Sulfolyser2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-WH2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-NR2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-NR(L)2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-IM2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-FB2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-4DS2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-4DL2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Stromatolyser-3WP2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Quicklyser II2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Lysercell WPC2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Lysercell WNR2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Lysercell WDF2007-05-07
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
XW CELLCLEAN1998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Manoresh1998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CyFlow CLEAN1998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Concentrated phosphate buffer for SP pH 7.21998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Concentrated phosphate buffer for SP pH 7.01998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Concentrated phosphate buffer for SP pH 6.81998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
Concentrated phosphate buffer for SP pH 6.61998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CELLCLEAN1998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CELLCLEAN AUTO1998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CA CLEAN II1998-05-06
Sysmex International Reagents Co., LTD ONO FACTORY [SYSMEX CORPORATION]
CA CLEAN I1998-05-06

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