thermofisher.comTest, Qualitative, For HLA, Non-Diagnostic
One Lambda, Inc.
ONE LAMBDA, INC.
FDA Registration(s)#
| 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 |
| 3013058950 | 3013058950 | ONE LAMBDA, INC | 1 | N | 2026-01-01 | Neuendorfstr. 25 room 03.206 Hennigsdorf Brandenburg DE 16761 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 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 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission |
|---|---|---|
| 34465 | 1194980921 | BR220737 |
| 195488 | 1194980921 | BR220737 |
| 195488 | 1530380678 | BK980015 |
| 34465 | 1530380678 | BK980015 |
| 195488 | 1565410323 | BK960062 |
| 34465 | 1565410323 | BK960062 |
| 195488 | 1372095189 | BK960053 |
| 34465 | 1372095189 | BK960053 |
| 195488 | 1701652496 | BK960011 |
| 34465 | 1701652496 | BK960011 |
| 34465 | 1056098459 | BK920009 |
| 195488 | 1056098459 | BK920009 |
| 34465 | 1210966370 | BK840013 |
| 195488 | 1210966370 | BK840013 |
| 34465 | 1666297326 | BK241074 |
| 195488 | 1666297326 | BK241074 |
| 195488 | 1528142795 | BK200546 |
| 34465 | 1528142795 | BK200546 |
| 195488 | 1737480108 | BK170053 |
| 34465 | 1737480108 | BK170053 |
| 34465 | 1008683918 | BK160018 |
| 195488 | 1008683918 | BK160018 |
| 195488 | 1948980100 | BK160017 |
| 34465 | 1948980100 | BK160017 |
| 195488 | 1420325123 | BK140141 |
| 34465 | 1420325123 | BK140141 |
| 34465 | 1251878099 | BK130009 |
| 195488 | 1251878099 | BK130009 |
| 34465 | 1684301832 | BK120024 |
| 195488 | 1684301832 | BK120024 |
| 34465 | 1595114070 | BK120014 |
| 195488 | 1595114070 | BK120014 |
| 195488 | 1813891555 | BK110038 |
| 34465 | 1813891555 | BK110038 |
| 195488 | 1612332259 | BK100068 |
| 34465 | 1612332259 | BK100068 |
| 34465 | 1436012892 | BK080071 |
| 195488 | 1436012892 | BK080071 |
| 195488 | 1481454884 | BK070070 |
| 34465 | 1481454884 | BK070070 |
| 34465 | 1549859497 | BK070038 |
| 195488 | 1549859497 | BK070038 |
| 195488 | 1890013156 | BK050071 |
| 34465 | 1890013156 | BK050071 |
| 195488 | 1424376655 | BK050070 |
| 34465 | 1424376655 | BK050070 |
| 195488 | 1316569068 | BK030069 |
| 34465 | 1316569068 | BK030069 |
| 195488 | 1087283072 | BK030003 |
| 34465 | 1087283072 | BK030003 |
| 195488 | 1800171450 | BK020068 |
| 34465 | 1800171450 | BK020068 |
| 34465 | 1435896855 | BK020055 |
| 195488 | 1435896855 | BK020055 |
| 195488 | 1781905232 | BK000019 |
| 34465 | 1781905232 | BK000019 |
| 195488 | 1044057831 | |
| 195488 | 1346325765 | |
| 195488 | 1523573357 | |
| 195488 | 1747885943 | |
| 195488 | 1956184452 | |
| 34465 | 1044057831 | |
| 195488 | 1299795639 | |
| 34465 | 1299795639 | |
| 34465 | 1346325765 | |
| 34465 | 1511800468 | |
| 195488 | 1511800468 | |
| 34465 | 1523573357 | |
| 34465 | 1747885943 | |
| 34465 | 1956184452 |
PMN#
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Qualitative Test For HLA, Non-diagnostic
One Lambda, Inc.
Empty Containers For The Collection & Processing Of Blood/Blood Components
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
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.
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.
2023-01-30
Micro SSP™ Gel System - 108 Wells - The Micro SSP Gel Box System is a compact gel box for electrophoresis.
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2018-05-31
FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml - FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.
2018-05-31
FluoroQuench Acridine Orange/Ethidium Bromide - 500ml - FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.
2018-05-31
FluoroQuench Acridine Orange/Ethidium Bromide - 100ml - FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2017-04-28
LABType™ SSO Class II DRB3,4,5 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.
2017-04-28
LABType™ SSO Class II DRB1 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.
2017-04-28
LABType™ SSO Class II DQA1/DQB1 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.
2017-04-28
LABType™ SSO Class II DPA1/DPB1 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.
2017-04-28
LABType™ SSO Class I C Locus Typing Test - Sample - DNA typing of HLA Class I or Class II alleles.
2017-04-28