Susan Durham

FDA Filings

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

FDA Registration(s)
Registration Number3012544827
FEI Number3012544827
NameSusan Durham
Owner & OperatorDia.Metra Srl
Contact AddressVia Pozzuolo 14
SPELLO IT-PG Perugia 06038 IT
Official Correspondent
  • Mick Henderson
  • 39-074-224851-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address948 Clopper Rd
Gaithersburg, MD 20878 US
Establishment TypeManufacture Medical Device



Registration Number9615777
FEI Number3007034602
NameSusan Durham
Owner & OperatorIMMUNODIAGNOSTIC SYSTEMS LTD.
Contact Address10 DIDCOT WAY BOLDON BUSINESS PARK
BOLDON COLLIERY GB-NOTA NE35 9PD GB
Official Correspondent
  • Mick - Henderson
  • 44-191-5190660-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address948 Clopper Rd
Gaithersburg, MD 20878 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Susan Durham [Dia.Metra Srl]
T4 ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
FT4 ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
Progesterone saliva ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
Progesterone ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
17OH Progesterone ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
C-Peptide ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
DHEA-S saliva ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
DHEA-S ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
Fetuin A2017-07-03
Susan Durham [Dia.Metra Srl]
Androstenedione saliva ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
Androstenedione ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
FSH ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
Free Estriol ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
Prolactin ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
Insulin ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
LH ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
T3 ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
FT3 ELISA2017-07-03
Susan Durham [Dia.Metra Srl]
RADIOIMMUNOASSAY, ESTRADIOL2016-11-03
Susan Durham [Dia.Metra Srl]
Estradiol saliva ELISA2016-11-03
Susan Durham [Dia.Metra Srl]
Estradiol ELISA2016-11-03
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Multi Discipline Automated System2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D Control Set2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-i102010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Multi Discipline Automated System2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D Control Set2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-i102010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Multi Discipline Automated System2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS 25-Hydroxy Vitamin D Control Set2010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-i102010-07-13
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Wash Solution2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Wash Solution (Wash S)2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Trigger Set2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS System Liquid2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS System Liquid (Syst.l)2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS D-Sorb Solution2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Cuvettes2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Cartridge Check System (CCS)2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS-iSYS Analyser2009-12-02
Susan Durham [IMMUNODIAGNOSTIC SYSTEMS LTD.]
IDS Immunocleaner2009-12-02

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