ONE LAMBDA, INC

FDA Device Registration & Listing · Hennigsdorf Brandenburg, DE · Registration 3013058950

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
3013058950
FEI Number
3013058950
Entity Name
ONE LAMBDA, INC
City/State/Country
Hennigsdorf Brandenburg, DE
Establishment Address
Neuendorfstr. 25, room 03.206, Hennigsdorf Brandenburg 16761, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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

One Lambda HLA PRO UniMatch Plus Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody AllSet Gold SSP LABScreen for use with LABScan 3D LABScreen Multi HLA High Resolution SSP Unitray Terasaki Tissue Typing Trays and Lambda Monoclonal Trays Micro SSP Gel System SeCore™ CDx HLA Sequencing System HLA Fusion Software version 3 LABScreen Lambda Jet MT III, v 1.2 LABXpress Reflex Commander Pippeter Fluoroquench Staining/Quench Reagent Stain Fix LABScreen Multi Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software Lympho-Kwik Fluorobeads UniTray SSP HLA Typing Kits HNA Genotyping HLA Fusion Software LABType SSO Typing Tests Micro SSP DNA Typing Tests LABType SSO DNA Typing Tests for use with LABScan 3D HLA Fusion Software

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis Clinical Chemistry Class 1 862.2750 2025-01-13
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 2015-05-29
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2013-12-18
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2016-03-16
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2015-09-24
LGO Test, Leukocyte Typing Hematology Class 1 864.7675 1992-06-29
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 2013-12-18
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2011-04-20
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2010-08-26
KQC Stains, Hematology Hematology Class 1 864.1850 2013-09-17
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 2015-05-29
JCF Lymphocyte Separation Medium Hematology Class 1 864.8500 2013-02-19
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2015-09-24
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 2011-04-20
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 2013-11-13
MZI Test, Qualitative, For Hla, Non-Diagnostic Unknown Class U N/A 2017-03-22

Official Correspondent

Angela Estany

US Agent Details

Angela Estany Business: One Lambda, Inc. Email: john.nelson2@thermofisher.com Phone: (747) 4941862

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
2024375 ONE LAMBDA, INC. West Hills, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K851403 Ventrex Laboratories, Inc. VENTREZYME ALLERGEN DATA REDUCTION SYSTEM 1985-06-21
K761290 Nuclear Medical Laboratories, Inc. COMPU-PET 300 1977-02-24
K770210 G.D. Searle and Co. ANALYTIX AUTO SAMPLE PREP. STA. 1600 1977-02-14
K791007 Bioscientific STAT DIFF STAIN 1979-08-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2025 Becton, Dickinson and Company, BD Bio Sciences 1
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
Z-0002-2013 Beckman Coulter Inc. 1
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012 Beckman Coulter Inc. 1
Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
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 3013058950. Last updated year: 2026. Please use registration number 3013058950 when referencing this establishment in official correspondence.
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