Angela Estany

FDA Filings

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

FDA Registration(s)
Registration Number3013058950
FEI Number3013058950
NameAngela Estany
Owner & OperatorONE LAMBDA, INC.
Contact Address22801 Roscoe Blvd --
West Hills CA 91304 US
Official Correspondent
  • Nicole - Brockway
  • 1-747-4941000-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address22801 Roscoe Blvd
West Hills, CA 91304 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Angela Estany [ONE LAMBDA, INC.]
LABTypeTM XR and CWD DNA Typing Test2017-12-28
Angela Estany [ONE LAMBDA, INC.]
LABType XR and CWD DNA Typing Tests2017-03-22
Angela Estany [ONE LAMBDA, INC.]
HLA Fusion Software2017-03-22
Angela Estany [ONE LAMBDA, INC.]
LABScreen Multi2016-03-16
Angela Estany [ONE LAMBDA, INC.]
HLA High Resolution SSP Unitray2015-09-24
Angela Estany [ONE LAMBDA, INC.]
UniTray SSP HLA Typing Kits2015-09-24
Angela Estany [ONE LAMBDA, INC.]
Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software2015-05-29
Angela Estany [ONE LAMBDA, INC.]
AllSet Gold SSP2015-05-29
Angela Estany [ONE LAMBDA, INC.]
UniMatch Plus2015-05-29
Angela Estany [ONE LAMBDA, INC.]
C1qScreen2015-01-27
Angela Estany [ONE LAMBDA, INC.]
C1qScreen Negative Control Serum2015-01-27
Angela Estany [ONE LAMBDA, INC.]
C1qScreen Class II Postivie Control2015-01-27
Angela Estany [ONE LAMBDA, INC.]
C1qScreen Class I Positive Control2015-01-27
Angela Estany [ONE LAMBDA, INC.]
LABScreen for use with LABScan 3D2013-12-18
Angela Estany [ONE LAMBDA, INC.]
HLA Fusion Software version 3.02013-12-18
Angela Estany [ONE LAMBDA, INC.]
LABType SSO DNA Typing Tests for use with LABScan 3D2013-11-13
Angela Estany [ONE LAMBDA, INC.]
Stain Fix2013-09-17
Angela Estany [ONE LAMBDA, INC.]
Fluoroquench Staining/Quench Reagent2013-09-17
Angela Estany [ONE LAMBDA, INC.]
Lympho-Kwik2013-02-19
Angela Estany [ONE LAMBDA, INC.]
Fluorobeads2013-02-19
Angela Estany [ONE LAMBDA, INC.]
FlowPRA2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Lambda Antigen Trays2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Anti-B27 FITC Conjugated Monoclonal Antibody2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Lambda Cell Tray2012-09-27
Angela Estany [ONE LAMBDA, INC.]
HNA Genotyping2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Micro SSP DNA Typing Tests2011-04-20
Angela Estany [ONE LAMBDA, INC.]
LABScreen Multi2011-04-20
Angela Estany [ONE LAMBDA, INC.]
HLA Fusion Software2011-04-20
Angela Estany [ONE LAMBDA, INC.]
HLA Tools Software2011-04-20
Angela Estany [ONE LAMBDA, INC.]
HLA Visual Software2011-04-20
Angela Estany [ONE LAMBDA, INC.]
LABScreen2011-04-20
Angela Estany [ONE LAMBDA, INC.]
LABType SSO Typing Tests2011-04-20
Angela Estany [ONE LAMBDA, INC.]
Lambda Jet MT III, v 1.22010-08-26
Angela Estany [ONE LAMBDA, INC.]
LABXpress Reflex Commander Pippeter2010-08-26
Angela Estany [ONE LAMBDA, INC.]
Terasaki Tissue Typing Trays and Lambda Monoclonal Trays1992-06-29

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