ONE LAMBDA, INC.

Matched from indexed company URL: One Lambda, Inc

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2024375	2024375	ONE LAMBDA, INC.	1	N	2026-01-01	22801 Roscoe Blvd. West Hills CA US 91304

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00812117010199	LABScreen™ Single Antigen HLA Class I ExPlex - LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology	800.822.8824	1lambda-TechSupport@thermofisher.com
00812117014654	LABScreen™ Single Antigen HLA Class II ExPlex - LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology	800.822.8824	1lambda-TechSupport@thermofisher.com
00812117015484	PE-Conjugated Streptavidin - For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO TYPING TESTS and LABType XR and CWD DNA Typing Test assays.	800.822.8824	1lambda-TechSupport@thermofisher.com

thermofisher.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission
34465	1194980921	BR220737
34465	1530380678	BK980015
34465	1565410323	BK960062
34465	1372095189	BK960053
34465	1701652496	BK960011
34465	1056098459	BK920009
34465	1210966370	BK840013
34465	1666297326	BK241074
34465	1528142795	BK200546
34465	1737480108	BK170053
34465	1008683918	BK160018
34465	1948980100	BK160017
34465	1420325123	BK140141
34465	1251878099	BK130009
34465	1684301832	BK120024
34465	1595114070	BK120014
34465	1813891555	BK110038
34465	1612332259	BK100068
34465	1436012892	BK080071
34465	1481454884	BK070070
34465	1549859497	BK070038
34465	1890013156	BK050071
34465	1424376655	BK050070
34465	1316569068	BK030069
34465	1087283072	BK030003
34465	1800171450	BK020068
34465	1435896855	BK020055
34465	1781905232	BK000019
34465	1044057831
34465	1299795639
34465	1346325765
34465	1511800468
34465	1523573357
34465	1747885943
34465	1956184452

PMN#

Test, Qualitative, For HLA, Non-Diagnostic

2021-01-07

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2017-10-05

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2017-03-08

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2017-03-06

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2014-11-25

One Lambda, Inc

Qualitative Test For HLA, Non-diagnostic

2013-11-06

One Lambda, Inc

Qualitative Test For HLA, Non-diagnostic

2012-12-20

One Lambda, Inc

Qualitative Test For HLA, Non-diagnostic

2012-12-18

One Lambda, Inc

Qualitative Test For HLA, Non-diagnostic

2011-08-25

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2009-04-10

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2008-03-10

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2006-01-30

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2006-01-30

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2003-12-31

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

2003-02-04

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

1999-07-23

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

1998-02-11

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

1997-07-03

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

1997-03-28

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

1996-10-30

One Lambda, Inc.

Qualitative Test For HLA, Non-diagnostic

1992-12-28

One Lambda, Inc.

Empty Containers For The Collection & Processing Of Blood/Blood Components

1992-06-08

One Lambda, Inc.

GUDID#

uTYPE™ CDx HLA Sequence Analysis Software - The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system

ONE LAMBDA, INC.

2023-01-30

SeCore™ CDx HLA GSSP Kit - The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.

ONE LAMBDA, INC.

2023-01-30

SeCore™ CDx HLA A Locus Sequencing Kit - The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.

ONE LAMBDA, INC.

2023-01-30

Micro SSP™ Gel System - 108 Wells - The Micro SSP Gel Box System is a compact gel box for electrophoresis.

ONE LAMBDA, INC.

2018-06-15

PE-Conjugated Streptavidin - For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO TYPING TESTS and LABType XR and CWD DNA Typing Test assays.

ONE LAMBDA, INC.

2020-06-04

LABScreen™ Single Antigen HLA Class II ExPlex - LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology

ONE LAMBDA, INC.

2020-06-03

LABScreen™ Single Antigen HLA Class I ExPlex - LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology

ONE LAMBDA, INC.

2020-06-03

UniMatch™ Plus Software - UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.

ONE LAMBDA, INC.

2016-08-31

Adsorb Out - To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antibody detection assays.

ONE LAMBDA, INC.

2018-06-15

Phosphate Buffered Saline/Citrate Reagent - FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.

ONE LAMBDA, INC.

2018-05-31

Lympho-Kwik T Lymphocyte, 25 isolations - Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.

ONE LAMBDA, INC.

2018-05-31

Lympho-Kwik T/B Lymphocyte, 50 isolations - Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.

ONE LAMBDA, INC.

2018-05-31

Lympho-Kwik T Lymphocyte, 50 isolations - Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.

ONE LAMBDA, INC.

2018-05-31

Lympho-Kwik Mononuclear Cell, 50 isolations - Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.

ONE LAMBDA, INC.

2018-05-31

FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml - FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.

ONE LAMBDA, INC.

2018-05-31

Fluorobeads™ B Lymphocyte – 100 Isolations - FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.

ONE LAMBDA, INC.

2018-05-31

FluoroBeads™ T Developer (10X) - FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescent dyes. FluoroBeads-T Developer is specifically designed to be used in the FluoroBeads-T isolation method.

ONE LAMBDA, INC.

2018-05-31

Fluorobeads™ T Lymphocyte – 100 Isolations - FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescent dyes. FluoroBeads-T Developer is specifically designed to be used in the FluoroBeads-T isolation method.

ONE LAMBDA, INC.

2018-05-31

Lympho-Kwik T/B Lymphocyte, 25 isolations - Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.

ONE LAMBDA, INC.

2018-05-31

FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml - FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.

ONE LAMBDA, INC.

2018-05-31

FluoroQuench Acridine Orange/Ethidium Bromide - 500ml - FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.

ONE LAMBDA, INC.

2018-05-31

FluoroQuench Acridine Orange/Ethidium Bromide - 100ml - FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.

ONE LAMBDA, INC.

2018-05-31

Fluorobeads™ B Lymphocyte – 25 Isolations - FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.

ONE LAMBDA, INC.

2018-05-31

Fluorobeads™ T Lymphocyte – 25 Isolations - FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescent dyes. FluoroBeads-T Developer is specifically designed to be used in the FluoroBeads-T isolation method.

ONE LAMBDA, INC.

2018-05-31

SeCore™ GSSP Kit - SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).

ONE LAMBDA, INC.

2018-04-27

LABType™ CWD Class I C Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2018-03-16

LABType™ CWD Class I C Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2018-03-16

LABType™ XR Class I C Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2018-03-16

LABType™ XR Class I C Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2018-03-16

LABType™ CWD Class II DRB1 Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2017-04-28

LABType™ CWD Class I B Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2017-04-28

LABType™ CWD Class I A Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2017-04-28

LABType™ XR Class II DRB1 Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2017-04-28

LABType™ XR Class I B Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2017-04-28

LABType™ XR Class I A Locus Typing Test - Sample - HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

2017-04-28

LABType™ SSO Class II DRB3,4,5 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.

ONE LAMBDA, INC.

2017-04-28

LABType™ SSO Class II DRB1 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.

ONE LAMBDA, INC.

2017-04-28

LABType™ SSO Class II DQA1/DQB1 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.

ONE LAMBDA, INC.

2017-04-28

LABType™ SSO Class II DPA1/DPB1 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.

ONE LAMBDA, INC.

2017-04-28

LABType™ SSO Class I C Locus Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.

ONE LAMBDA, INC.

2017-04-28

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