ONE LAMBDA, INC.

FDA Device Registration & Listing · West Hills, CA, US · Registration 2024375

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2024375
FEI Number
2024375
Entity Name
ONE LAMBDA, INC.
City/State/Country
West Hills, CA, US
Establishment Address
22801 Roscoe Blvd., West Hills, CA 91304, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
One Lambda, Inc. (Owner Number: 2024375)
Owner / Operator Contact Address
22801 Roscoe Blvd, --, West Hills, CA 91304, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK160017
PMA Number
N/A

All Registered Proprietary Names

Lambda Cell Tray AllSet Gold SSP HLA Fusion Software version 3 Fluoroquench Staining/Quench Reagent Stain Fix LABScreen for use with LABScan 3D Terasaki Tissue Typing Trays and Lambda Monoclonal Trays Lympho-Kwik Fluorobeads HNA Genotyping FlowPRA LABType XR and CWD DNA Typing Tests Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software Anti-B27 FITC Conjugated Monoclonal Antibody LABScreen LABTypeTM XR and CWD DNA Typing Test LABType SSO DNA Typing Tests for use with LABScan 3D Micro SSP DNA Typing Tests HLA High Resolution SSP Unitray C1qScreen Negative Control Serum C1qScreen C1qScreen Class I Positive Control C1qScreen Class II Postivie Control SureTyper Software LinkSeq HLA Typing Kit AllType FASTplex NGS 11 Loci Flex Kit – 96 TypeStream Visual Software AllType Next Generation Sequencing (NGS) 11 Loci Amplification Kit AllType FASTplex NGS 11 Loci Kit – 48 LABScreen Multi Micro SSP Gel System SeCore™ CDx HLA Sequencing System HLA Fusion Software Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody LABScreen™ Multi UniTray SSP HLA Typing Kits HLA Fusion Software

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2012-09-27
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2015-05-29
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2013-12-18
KQC Stains, Hematology Hematology Class 1 864.1850 2013-09-17
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2013-12-18
LGO Test, Leukocyte Typing Hematology Class 1 864.7675 1992-06-29
JCF Lymphocyte Separation Medium Hematology Class 1 864.8500 2013-02-19
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2012-09-27
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2012-09-27
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2017-03-22
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2015-05-29
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2012-09-27
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2011-04-20
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2017-12-28
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2013-11-13
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2011-04-20
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2015-09-24
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2015-01-27
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2016-03-16
JJN Apparatus, Electrophoresis, For Clinical Use Clinical Chemistry Class 1 862.2485 2017-11-03
QUK Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test Immunology Class 2 866.5960 2024-11-21
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2011-04-20
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2012-09-27
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2021-02-17
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2015-09-24
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2017-03-22

Official Correspondent

Angela Estany

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

One Lambda, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013058950 ONE LAMBDA, INC Hennigsdorf Brandenburg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K791007 Bioscientific STAT DIFF STAIN 1979-08-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2012 EMD Chemicals Inc. 1
Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024375. Last updated year: 2026. Please use registration number 2024375 when referencing this establishment in official correspondence.
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