Orgentec

FDA Filings

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

FDA Registration(s)
Registration Number3003232042
FEI Number3003232042
NameDaniel Simpson
Owner & OperatorORGENTEC
Contact AddressCARL-ZEISS-STRASSE 49 --
MAINZ DE-NOTA 55129 DE
US Agent
Importing Logistics Registration
ImporterEXAGEN DIAGNOSTICS
Address801 UNIVERSITY BLVD SE
Albuquerque, NM 87106 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address11575 Main Street, Suite 400
Broomfield, CO 80020 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Daniel Simpson [ORGENTEC]
ORGENTEC anti-PR3 ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-MPO ELISA Kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-Cardiolipin Screen2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-Cardiolipin IgA ELISA2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-Sm ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-RNP/Sm ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-Scl-702007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-SS-A ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-Jo-1 ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-SS-B ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-Cardiolipin IgG/IgM2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC ENA Screen ELISA2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC anti-dsDNA ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
System, Test, Thyroid autoantibody2007-12-04
Daniel Simpson [ORGENTEC]
System, Test, Thyroid, autoantibody2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC ANA Detect ELISA kit2007-12-04
Daniel Simpson [ORGENTEC]
ORGENTEC ANA Detect ELISA kit2007-12-04
ORGENTEC
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY1996-05-08
ORGENTEC
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY1996-05-08
ORGENTEC
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY1996-04-18
ORGENTEC
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY1996-04-18
ORGENTEC
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY1996-04-18
ORGENTEC
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY1996-04-18
Daniel Simpson [ORGENTEC]
ORGENTEC MICROALBUMIN ASSAY1996-04-10
ORGENTEC
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY1996-03-29
ORGENTEC
ORGENTEC ENASCREEN ELISA ASSAY1996-03-20
ORGENTEC
ORGENTEC ENASCREEN PIN IMMUNO ASSAY1996-03-20
ORGENTEC
ORGEN TEC ANTI-DSDNA ELISA ASSAY1995-11-09

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Related Finance Registrations
NCAGE CodeFB5T3ORGENTEC
CAGE CodeFB5T3ORGENTEC
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