One Lambda Inc

FDA Filings

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

FDA Registration(s)
Registration Number2024375
FEI Number2024375
NameONE LAMBDA, INC.
Owner & OperatorONE LAMBDA, INC.
Contact Address22801 Roscoe Blvd --
West Hills CA 91304 US
Official Correspondent
  • Nicole - Brockway
  • 1-747-4941000-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address22801 Roscoe Blvd.
West Hills, CA 91304 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



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
One Lambda, Inc.
Test, Qualitative, For HLA, Non-Diagnostic2021-01-07
ONE LAMBDA, INC.
PE-Conjugated Streptavidin LSPSAB22020-06-12
ONE LAMBDA, INC.
LABScreen™ Single Antigen HLA Class II ExPlex LS2AEX012020-06-11
ONE LAMBDA, INC.
LABScreen™ Single Antigen HLA Class I ExPlex LS1AEX012020-06-11
ONE LAMBDA, INC.
UniMatch™ Plus Software 7901112019-01-23
ONE LAMBDA, INC.
Micro SSP™ Gel System - 108 Wells MGS1082018-07-16
ONE LAMBDA, INC.
Adsorb Out ADSORB2018-07-16
ONE LAMBDA, INC.
Phosphate Buffered Saline/Citrate Reagent PC1-5002018-07-02
ONE LAMBDA, INC.
Lympho-Kwik T Lymphocyte, 25 isolations LKT252018-07-02
ONE LAMBDA, INC.
Lympho-Kwik T/B Lymphocyte, 50 isolations LK-50-TB2018-07-02
ONE LAMBDA, INC.
Lympho-Kwik T Lymphocyte, 50 isolations LK-50-T2018-07-02
ONE LAMBDA, INC.
Lympho-Kwik Mononuclear Cell, 50 isolations LK-50-MN2018-07-02
ONE LAMBDA, INC.
FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml FQZAE1002018-07-02
ONE LAMBDA, INC.
Fluorobeads™ B Lymphocyte – 100 Isolations FB2-1002018-07-02
ONE LAMBDA, INC.
FluoroBeads™ T Developer (10X) FB1-DEV2018-07-02
ONE LAMBDA, INC.
Fluorobeads™ T Lymphocyte – 100 Isolations FB1-1002018-07-02
ONE LAMBDA, INC.
Lympho-Kwik T/B Lymphocyte, 25 isolations LKTB252018-07-02
ONE LAMBDA, INC.
FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml FQAE20002018-07-02
ONE LAMBDA, INC.
FluoroQuench Acridine Orange/Ethidium Bromide - 500ml FQAE5002018-07-02
ONE LAMBDA, INC.
FluoroQuench Acridine Orange/Ethidium Bromide - 100ml FQAE1002018-07-02
ONE LAMBDA, INC.
Fluorobeads™ B Lymphocyte – 25 Isolations FB2-252018-07-02
ONE LAMBDA, INC.
Fluorobeads™ T Lymphocyte – 25 Isolations FB1-252018-07-02
ONE LAMBDA, INC.
SeCore™ GSSP Kit A112562018-05-28
ONE LAMBDA, INC.
LABType™ CWD Class I C Locus Typing Test - Sample RSSOW1CRS2018-04-16
ONE LAMBDA, INC.
LABType™ CWD Class I C Locus Typing Test - Sample RSSOW1CS2018-04-16
ONE LAMBDA, INC.
LABType™ XR Class I C Locus Typing Test - Sample RSSOX1CRS2018-04-16
ONE LAMBDA, INC.
LABType™ XR Class I C Locus Typing Test - Sample RSSOX1CS2018-04-16
ONE LAMBDA, INC.
Micro SSP™ Generic HLA Class I DNA Typing Tray SSP1L2018-03-29
ONE LAMBDA, INC.
LABScreen™ Single Antigen HLA Class II - Group 1 LS2A012018-03-29
ONE LAMBDA, INC.
LABScreen™ MICA Single Antigen - Group 1 LSMICA0012018-03-29
ONE LAMBDA, INC.
LABScreen™ Single Antigen HLA Class I - Combi LS1A042018-03-29
ONE LAMBDA, INC.
LABScreen™ Mixed Class I & II LSM122018-03-29
ONE LAMBDA, INC.
LABScreen™ PRA Class I & II LS12PRA2018-03-29
ONE LAMBDA, INC.
LABScreen™ PRA Class II LS2PRA2018-03-29
ONE LAMBDA, INC.
LABScreen™ PRA Class I LS1PRA2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Control Beads FLCNTBD2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Negative Control FL-NC2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Class Il Positive Control FL2-PC2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Class l Positive Control FL1-PC2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class II Supplement - 5 Antibody Detection Test FL2HD052018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class II - 4 Antibody Detection Test FL2HD042018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class II - 3 Antibody Detection Test FL2HD032018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class II - 2 Antibody Detection Test FL2HD022018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class II - 1 Antibody Detection Test FL2HD012018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class II Antibody Detection Test FL2HD2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I Supplement - 10 Antibody Detection Test FL1HD102018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I Supplement - 9 Antibody Detection Test FL1HD092018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I Supplement - 8 Antibody Detection Test FL1HD082018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I Supplement - 7 Antibody Detection Test FL1HD072018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I Supplement - 6 Antibody Detection Test FL1HD062018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I Supplement - 5 Antibody Detection Test FL1HD052018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I - 4 Antibody Detection Test FL1HD042018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I - 3 Antibody Detection Test FL1HD032018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I - 2 Antibody Detection Test FL1HD022018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I - 1 Antibody Detection Test FL1HD012018-03-29
ONE LAMBDA, INC.
FlowPRA™ Single Antigen HLA Class I Antibody Detection Test FL1HD2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Specific HLA Class II Antibody Detection Test FL2SP2018-03-29
ONE LAMBDA, INC.
FlowPRA™ Specific HLA Class I Antibody Detection Test FL1SP2018-03-29
ONE LAMBDA, INC.
FlowPRA™ HLA Class II Screening Test FL2-302018-03-29
ONE LAMBDA, INC.
FlowPRA™ HLA Class I Screening Test FL1-302018-03-29
ONE LAMBDA, INC.
FlowPRA™ HLA Class I & II Screening Test FL12-602018-03-29
ONE LAMBDA, INC.
LABType™ SSO MICA RSSOMICA2018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class II DQA1/DQB1 Typing Test RSSO2Q2018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class I B7 Supplement Typing Test RSSO1S12018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class I Bw4 Supplement Typing Test RSSO1S42018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class II DRB3,4,5 Typing Test RSSO23452018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class II DRB1 Typing Test RSSO2B12018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class I C Locus Typing Test RSSO1C2018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class I B Locus Typing Test RSSO1B2018-03-29
ONE LAMBDA, INC.
LABType™ SSO Class I A Locus Typing Test RSSO1A2018-03-29
ONE LAMBDA, INC.
Fast Monoclonal Trays™ Class II FTDR722018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ HLA Class I (Oriental) LM72OR2018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ HLA Class I - 96 well LM962018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ Second HLA Class II MDR2722018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ First HLA Class II MDR1722018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ First HLA Class II - 60 well MDR1602018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ Set HLA Class I 2LM722018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ Set HLA Class I (B) LM144B2018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ Set HLA Class I (A) LM144A2018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ Set HLA Class I (A,B) - 2-tray set LM1442018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ Third HLA Class I LM3722018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ HLA B27 tray (3 test/tray) LMB27032018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ HLA B27 tray LMB27012018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ Second HLA Class I LM2722018-03-29
ONE LAMBDA, INC.
Lambda Monoclonal Trays™ First HLA Class I LM1722018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class I Asian Dry Tissue Typing Tray ASN72D2018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class I Dry Tissue Typing Tray AB72D2018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class I ABC Tissue Typing Tray - (B) TS144B2018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class I ABC Tissue Typing Tray - (A) TS144A2018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class I Tissue Typing Tray Set (B) TM144B2018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class I Tissue Typing Tray Set (A) TM144A2018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class II Tissue Typing Tray DR722018-03-29
ONE LAMBDA, INC.
Terasaki HLA Class I Tissue Typing Tray Set TM1442018-03-29
ONE LAMBDA, INC.
Terasaki HLA-C Locus Tissue Typing Tray C7222018-03-29
ONE LAMBDA, INC.
Terasaki HLA-B7/40 Supplement Tissue Typing Tray BS740-722018-03-29
ONE LAMBDA, INC.
Terasaki HLA-B Locus Supplement Tissue Typing Tray BS722018-03-29
ONE LAMBDA, INC.
Terasaki HLA-A Locus Supplement Tissue Typing Tray AS722018-03-29
ONE LAMBDA, INC.
Terasaki HLA-ABC Oriental Tissue Typing Tray OT-722018-03-29
ONE LAMBDA, INC.
Terasaki HLA-C Locus Tissue Typing Tray C722018-03-29
ONE LAMBDA, INC.
Terasaki HLA-ABC Third Tissue Typing Tray T3-722018-03-29
ONE LAMBDA, INC.
Terasaki HLA-ABC First Tissue Typing Tray T1-722018-03-29
ONE LAMBDA, INC.
LABTypeTM XR and CWD DNA Typing Test2017-12-28
Angela Estany [ONE LAMBDA, INC.]
LABTypeTM XR and CWD DNA Typing Test2017-12-28
ONE LAMBDA, INC.
Micro SSP Gel System2017-11-03
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2017-10-05
ONE LAMBDA, INC.
LABType XR and CWD DNA Typing Tests2017-03-22
Angela Estany [ONE LAMBDA, INC.]
LABType XR and CWD DNA Typing Tests2017-03-22
ONE LAMBDA, INC.
HLA Fusion Software2017-03-22
Angela Estany [ONE LAMBDA, INC.]
HLA Fusion Software2017-03-22
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2017-03-08
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2017-03-06
ONE LAMBDA, INC.
LABScreen Multi2016-03-16
Angela Estany [ONE LAMBDA, INC.]
LABScreen Multi2016-03-16
ONE LAMBDA, INC.
HLA High Resolution SSP Unitray2015-09-24
Angela Estany [ONE LAMBDA, INC.]
HLA High Resolution SSP Unitray2015-09-24
ONE LAMBDA, INC.
UniTray SSP HLA Typing Kits2015-09-24
Angela Estany [ONE LAMBDA, INC.]
UniTray SSP HLA Typing Kits2015-09-24
ONE LAMBDA, INC.
Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software2015-05-29
Angela Estany [ONE LAMBDA, INC.]
Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software2015-05-29
ONE LAMBDA, INC.
AllSet Gold SSP2015-05-29
Angela Estany [ONE LAMBDA, INC.]
AllSet Gold SSP2015-05-29
ONE LAMBDA, INC.
UniMatch Plus2015-05-29
Angela Estany [ONE LAMBDA, INC.]
UniMatch Plus2015-05-29
ONE LAMBDA, INC.
C1qScreen2015-01-27
ONE LAMBDA, INC.
C1qScreen Negative Control Serum2015-01-27
ONE LAMBDA, INC.
C1qScreen Class II Postivie Control2015-01-27
ONE LAMBDA, INC.
C1qScreen Class I Positive Control2015-01-27
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
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic2014-11-25
ONE LAMBDA, INC.
LABScreen for use with LABScan 3D2013-12-18
Angela Estany [ONE LAMBDA, INC.]
LABScreen for use with LABScan 3D2013-12-18
ONE LAMBDA, INC.
HLA Fusion Software version 3.02013-12-18
Angela Estany [ONE LAMBDA, INC.]
HLA Fusion Software version 3.02013-12-18
ONE LAMBDA, INC.
LABType SSO DNA Typing Tests for use with LABScan 3D2013-11-13
Angela Estany [ONE LAMBDA, INC.]
LABType SSO DNA Typing Tests for use with LABScan 3D2013-11-13
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic2013-11-06
ONE LAMBDA, INC.
Stain Fix2013-09-17
ONE LAMBDA, INC.
Fluoroquench Staining/Quench Reagent2013-09-17
Angela Estany [ONE LAMBDA, INC.]
Stain Fix2013-09-17
Angela Estany [ONE LAMBDA, INC.]
Fluoroquench Staining/Quench Reagent2013-09-17
ONE LAMBDA, INC.
Lympho-Kwik2013-02-19
ONE LAMBDA, INC.
Fluorobeads2013-02-19
Angela Estany [ONE LAMBDA, INC.]
Lympho-Kwik2013-02-19
Angela Estany [ONE LAMBDA, INC.]
Fluorobeads2013-02-19
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic2012-12-20
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic2012-12-18
ONE LAMBDA, INC.
FlowPRA2012-09-27
Angela Estany [ONE LAMBDA, INC.]
FlowPRA2012-09-27
ONE LAMBDA, INC.
Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody2012-09-27
ONE LAMBDA, INC.
Lambda Antigen Trays2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Lambda Antigen Trays2012-09-27
ONE LAMBDA, INC.
Anti-B27 FITC Conjugated Monoclonal Antibody2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Anti-B27 FITC Conjugated Monoclonal Antibody2012-09-27
ONE LAMBDA, INC.
Lambda Cell Tray2012-09-27
Angela Estany [ONE LAMBDA, INC.]
Lambda Cell Tray2012-09-27
ONE LAMBDA, INC.
HNA Genotyping2012-09-27
Angela Estany [ONE LAMBDA, INC.]
HNA Genotyping2012-09-27
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2011-08-25
ONE LAMBDA, INC.
Micro SSP DNA Typing Tests2011-04-20
Angela Estany [ONE LAMBDA, INC.]
Micro SSP DNA Typing Tests2011-04-20
ONE LAMBDA, INC.
LABScreen Multi2011-04-20
Angela Estany [ONE LAMBDA, INC.]
LABScreen Multi2011-04-20
ONE LAMBDA, INC.
HLA Fusion Software2011-04-20
Angela Estany [ONE LAMBDA, INC.]
HLA Fusion Software2011-04-20
ONE LAMBDA, INC.
HLA Tools Software2011-04-20
Angela Estany [ONE LAMBDA, INC.]
HLA Tools Software2011-04-20
ONE LAMBDA, INC.
HLA Visual Software2011-04-20
Angela Estany [ONE LAMBDA, INC.]
HLA Visual Software2011-04-20
ONE LAMBDA, INC.
LABScreen2011-04-20
Angela Estany [ONE LAMBDA, INC.]
LABScreen2011-04-20
ONE LAMBDA, INC.
LABType SSO Typing Tests2011-04-20
Angela Estany [ONE LAMBDA, INC.]
LABType SSO Typing Tests2011-04-20
ONE LAMBDA, INC.
Lambda Jet MT III, v 1.22010-08-26
ONE LAMBDA, INC.
LABXpress Reflex Commander Pippeter2010-08-26
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
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2009-04-10
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2008-03-10
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2006-01-30
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2006-01-30
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2003-12-31
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic2003-02-04
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic1999-07-23
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic1998-02-11
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic1997-07-03
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic1997-03-28
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic1996-10-30
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic1992-12-28
ONE LAMBDA, INC.
Terasaki Tissue Typing Trays and Lambda Monoclonal Trays1992-06-29
Angela Estany [ONE LAMBDA, INC.]
Terasaki Tissue Typing Trays and Lambda Monoclonal Trays1992-06-29
One Lambda, Inc.
Empty Containers For The Collection & Processing Of Blood/Blood Components1992-06-08

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