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 Number: 3013058950
• FEI Number: 3013058950
• Name: Angela Estany
• Owner & Operator: ONE LAMBDA, INC.
• Contact Address: 22801 Roscoe Blvd --; West Hills CA 91304 US
• Official Correspondent:
  • Nicole - Brockway
  • 1-747-4941000-x
• US Agent:
  • Angela Estany
  • One Lambda
  • 747 4941346
  • angela.estany@thermofisher.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 22801 Roscoe Blvd ; West Hills, CA 91304 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN BK170053 | MZI Angela Estany [ONE LAMBDA, INC.]	LABTypeTM XR and CWD DNA Typing Test	2017-12-28
PMN BK160018 | MZI Angela Estany [ONE LAMBDA, INC.]	LABType XR and CWD DNA Typing Tests	2017-03-22
PMN BK160017 | MZI Angela Estany [ONE LAMBDA, INC.]	HLA Fusion Software	2017-03-22
PMN BK140141 | MZI Angela Estany [ONE LAMBDA, INC.]	LABScreen Multi	2016-03-16
PMN BK020068 | MZI Angela Estany [ONE LAMBDA, INC.]	HLA High Resolution SSP Unitray	2015-09-24
PMN BK000019 | MZI Angela Estany [ONE LAMBDA, INC.]	UniTray SSP HLA Typing Kits	2015-09-24
PMN BK110038 | MZI Angela Estany [ONE LAMBDA, INC.]	Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software	2015-05-29
PMN BK070038 | MZI Angela Estany [ONE LAMBDA, INC.]	AllSet Gold SSP	2015-05-29
PMN BK030003 | MZI Angela Estany [ONE LAMBDA, INC.]	UniMatch Plus	2015-05-29
MZI Angela Estany [ONE LAMBDA, INC.]	C1qScreen	2015-01-27
MZI Angela Estany [ONE LAMBDA, INC.]	C1qScreen Negative Control Serum	2015-01-27
MZI Angela Estany [ONE LAMBDA, INC.]	C1qScreen Class II Postivie Control	2015-01-27
MZI Angela Estany [ONE LAMBDA, INC.]	C1qScreen Class I Positive Control	2015-01-27
PMN BK130009 | MZI Angela Estany [ONE LAMBDA, INC.]	LABScreen for use with LABScan 3D	2013-12-18
PMN BK120014 | MZI Angela Estany [ONE LAMBDA, INC.]	HLA Fusion Software version 3.0	2013-12-18
PMN BK120024 | MZI Angela Estany [ONE LAMBDA, INC.]	LABType SSO DNA Typing Tests for use with LABScan 3D	2013-11-13
KQC Angela Estany [ONE LAMBDA, INC.]	Stain Fix	2013-09-17
KQC Angela Estany [ONE LAMBDA, INC.]	Fluoroquench Staining/Quench Reagent	2013-09-17
JCF Angela Estany [ONE LAMBDA, INC.]	Lympho-Kwik	2013-02-19
JCF Angela Estany [ONE LAMBDA, INC.]	Fluorobeads	2013-02-19
PMN BK980015 | MZI Angela Estany [ONE LAMBDA, INC.]	FlowPRA	2012-09-27
PMN BK960053 | MZI Angela Estany [ONE LAMBDA, INC.]	Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody	2012-09-27
PMN BK960011 | MZI Angela Estany [ONE LAMBDA, INC.]	Lambda Antigen Trays	2012-09-27
PMN BK920009 | MZI Angela Estany [ONE LAMBDA, INC.]	Anti-B27 FITC Conjugated Monoclonal Antibody	2012-09-27
PMN BK840013 | MZI Angela Estany [ONE LAMBDA, INC.]	Lambda Cell Tray	2012-09-27
PMN BK100068 | MZI Angela Estany [ONE LAMBDA, INC.]	HNA Genotyping	2012-09-27
PMN BK960062 | MZI Angela Estany [ONE LAMBDA, INC.]	Micro SSP DNA Typing Tests	2011-04-20
PMN BK080071 | MZI Angela Estany [ONE LAMBDA, INC.]	LABScreen Multi	2011-04-20
PMN BK070070 | MZI Angela Estany [ONE LAMBDA, INC.]	HLA Fusion Software	2011-04-20
PMN BK050071 | MZI Angela Estany [ONE LAMBDA, INC.]	HLA Tools Software	2011-04-20
PMN BK050070 | MZI Angela Estany [ONE LAMBDA, INC.]	HLA Visual Software	2011-04-20
PMN BK030069 | MZI Angela Estany [ONE LAMBDA, INC.]	LABScreen	2011-04-20
PMN BK020055 | MZI Angela Estany [ONE LAMBDA, INC.]	LABType SSO Typing Tests	2011-04-20
JQW Angela Estany [ONE LAMBDA, INC.]	Lambda Jet MT III, v 1.2	2010-08-26
JQW Angela Estany [ONE LAMBDA, INC.]	LABXpress Reflex Commander Pippeter	2010-08-26
LGO Angela Estany [ONE LAMBDA, INC.]	Terasaki Tissue Typing Trays and Lambda Monoclonal Trays	1992-06-29

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• One Lambda