Hyphen Biomed

FDA Filings

This page includes the latest FDA filings for Hyphen Biomed. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004434070
FEI Number3004434070
NameColleen Murphy
Owner & OperatorHYPHEN BIOMED
Contact Address155 RUE D' ERAGNY ZAC NEUVILLE - UNIVERSITE
NEUVILLE SUR OISE FR-NOTA 95000 FR
US Agent
Importing Logistics Registration
ImporterANIARA DIAGNOSTICA LLC
Address7768 SERVICE CENTER DR
West Chester, OH 45069 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7768 SERVICE CENTER DR WEST CHESTER
West Chester, OH 45069 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
HYPHEN BIOMED
 Imidazole buffer 2020-11-05
HYPHEN BIOMED
 Imidazole buffer 2020-11-05
HYPHEN BIOMED
 Imidazole buffer 2020-11-05
HYPHEN BIOMED
 BIOPHEN™ V-L Plasma Calibrator 2224012020-08-21
HYPHEN BIOMED
 BIOPHEN™ V-L Control Plasma 2234052020-08-21
HYPHEN BIOMED
 Imidazole buffer AR021L2020-07-08
HYPHEN BIOMED
 Imidazole buffer AR021K2020-07-08
HYPHEN BIOMED
 Calcium chloride 0.25M (M/4) AR002K2020-07-08
HYPHEN BIOMED
 Calcium chloride 0.25M (M/4) AR002A2020-07-08
HYPHEN BIOMED
 Calcium chloride 0.025M (M/40) 2020-07-08
HYPHEN BIOMED
 Calcium chloride 0.025M (M/40) AR001A2020-07-08
HYPHEN BIOMED
 Imidazole buffer AR021A2020-07-08
Colleen Murphy [HYPHEN BIOMED]
AR002K Calcium chloride 0,25M (M/4) Set of 3x25 ml2013-09-12
Colleen Murphy [HYPHEN BIOMED]
AR002A Calcium chloride 0,25M (M/4) 1x25 ml2013-09-12
Colleen Murphy [HYPHEN BIOMED]
AR001K Calcium chloride 0,025M (M/40) Set of 12x25 ml2013-09-12
Colleen Murphy [HYPHEN BIOMED]
AR001A Calcium chloride 0,025M (M/40) 3x25 ml2013-09-12
Colleen Murphy [HYPHEN BIOMED]
AR021L Imidazole buffer 12x25 ml2013-09-11
Colleen Murphy [HYPHEN BIOMED]
AR021K Imidazole buffer 3x25 ml2013-09-11
Colleen Murphy [HYPHEN BIOMED]
AR021A Imidazole buffer 1x25 ml2013-09-11
Colleen Murphy [HYPHEN BIOMED]
Hemoclot Quanti V-L (CK065K)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
FVL Calibrator (SC065K)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen VL Cal Undiluted (222401)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen Normal Ctrl Plasma (223201)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen ACT PC-r Ctl Plasma(223405)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Hemoclot Quanti V-L (CK065K)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
FVL Calibrator (SC065K)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen VL Cal Undiluted (222401)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen Normal Ctrl Plasma (223201)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen ACT PC-r Ctl Plasma(223405)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Hemoclot Quanti V-L (CK065K)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
FVL Calibrator (SC065K)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen VL Cal Undiluted (222401)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen Normal Ctrl Plasma (223201)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
Biophen ACT PC-r Ctl Plasma(223405)2009-06-09
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH Calibrator2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL PLASMA-2231012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL C2-2239012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL C1-2241012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW CII-2244012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW CI-2243012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL C4-2242012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL C3-2238012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN Heparin Calibrator2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH Calibrator2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL PLASMA-2231012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL C2-2239012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL C1-2241012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW CII-2244012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW CI-2243012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL C4-2242012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL C3-2238012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN Heparin Calibrator2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH Calibrator2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL PLASMA-2231012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL C2-2239012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN UFH CONTROL C1-2241012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW CII-2244012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL LOW CI-2243012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL C4-2242012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN LMWH CONTROL C3-2238012008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN Heparin Calibrator2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN HEPARIN 62008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN HEPARIN 32008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN PROTEIN C52008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN PROTEIN C 2.52008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN PLASMA CALIBRATOR2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN NORMAL PLASMA2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN ABNORMAL PLASMA2008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN ANTITROMBIN 52008-11-28
Colleen Murphy [HYPHEN BIOMED]
BIOPHEN ANTITHROMBIN 2.52008-11-28
HYPHEN BIOMED
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A2007-09-07
Colleen Murphy [HYPHEN BIOMED]
ZYMUTEST HIA MONOSTRIP IGGAM-RK041D2007-06-18
Colleen Murphy [HYPHEN BIOMED]
ZYMUTEST HIA MONOSTRIP IGG-RK041A2007-06-18
Colleen Murphy [HYPHEN BIOMED]
ZYMUTEST HIA IGGAM-RK040D2007-06-18
Colleen Murphy [HYPHEN BIOMED]
ZYMUTEST HIA IGG- RK040A2007-06-18
Colleen Murphy [HYPHEN BIOMED]
ZYMUTEST HIA IGG AND Z2007-06-18
HYPHEN BIOMED
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 62006-05-24
HYPHEN BIOMED
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 2212022005-12-27
HYPHEN BIOMED
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR2005-12-23
HYPHEN BIOMED
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 2211052005-11-07
HYPHEN BIOMED
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR2005-03-17

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