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ONE LAMBDA, INC.

United States·US-MF-000024901

Last updated September 17, 2026

What ONE LAMBDA, INC. makes

One Lambda, Inc. manufactures in vitro diagnostic (IVD) kits and reagents for human leukocyte antigen (HLA) class I and II antigen and antibody testing, including multiplex and single-locus typing solutions. Their portfolio also includes reagents for cell separation, DNA blocking, and automated slide staining for microscopy, as well as electrophoresis chambers for genetic analysis. Notable products include HLA typing kits for specific loci (e.g., HLA-ABC, HLA-B27, HLA-DRDQDP) and controls for antibody screening, such as C1qScreen reagents.

The company’s devices are classified under EU Class C, Class I, and Class II, as well as FDA’s Unclassified (U) category, reflecting varying levels of risk and regulatory oversight. Their products are registered in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system, ensuring compliance with international and U.S. regulatory requirements. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 22801, Roscoe Blvd. , West Hills, United States
Website: www.thermofisher.com/onelambda/us/en/home.html
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +(747)-494-1000
PRRC Contact: Sheryl Skinner
EUDAMED SRN: US-MF-000024901
FDA FEI Number: 2024375
DUNS Number: 118289289

Catalogue (448)

Page 4 of 9

Device	Model / Reference	Registries	Class	Status
Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*08	N/A	FDA UDI	U	Active
LABType™ SSO Class I B7 Supplement Typing Test - Sample	N/A	FDA UDI	U	Active
LABType™ CWD Class I C Locus Typing Test - Sample	N/A	FDA UDI	U	Active
Lambda Antigen Tray™ Class I & II - 1 test	N/A	FDA UDI	U	Active
LABType™ XR Class I B Locus Typing Test	N/A	FDA UDI	U	Active
FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml	N/A	FDA UDI	Class I	Active
LABScreen™ PRA Class II - Group 1 Sample	N/A	FDA UDI	U	Active
LABType™ XR Class II DRB1 Typing Test - Sample	N/A	FDA UDI	U	Active
LABType™ CWD Class I B Locus Typing Test	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*05	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DRB1*07/09 High Resolution Kit	N/A	FDA UDI	U	Active
LABType™ SSO Class I Bw4 Supplement Typing Test - 20 tests	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*68	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*25/34/66	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP A*23/24 High Resolution Kit	N/A	FDA UDI	U	Active
LABType™ HD Class I DRB1 Typing Test - 1000 tests	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DRB345 Locus High Resolution Kit	N/A	FDA UDI	U	Active
Lambda Antigen Tray™ Class I - Sample	N/A	FDA UDI	U	Active
LABType™ SSO Class II DRB1 Typing Test - 20 tests	N/A	FDA UDI	U	Active
Micro SSP™ HLA Class I DNA Typing Tray - AB	N/A	FDA UDI	U	Active
FlowPRA™ Single Antigen HLA Class II - 2 Antibody Detection Test	N/A	FDA UDI	N/A	Active
SeCore™ DRB1, DRB3, DRB4, DRB5 Locus Sequencing Kit Group Specific Set	N/A	FDA UDI	U	Active
LABScreen™ Single Antigen HLA Class I - Combi - Sample	N/A	FDA UDI	U	Active
Lambda Antigen Tray™ Class I	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP A*02 High Resolution Kit	N/A	FDA UDI	U	Active
FlowPRA™ HLA Class I Screening Test	N/A	FDA UDI	N/A	Active
FlowPRA™ Single Antigen HLA Class I Supplement - 5 Antibody Detection Test	N/A	FDA UDI	N/A	Active
LABType™ SSO Class II DRB1 Typing Test - Sample	N/A	FDA UDI	U	Active
FlowPRA™ Single Antigen HLA Class I Supplement - 6 Antibody Detection Test	N/A	FDA UDI	N/A	Active
HLA Class I Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP A*01/36 High Resolution Kit	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*07	N/A	FDA UDI	U	Active
LABType™ HD Class II DRB1 Typing Test - 20 tests	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB3	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*15	N/A	FDA UDI	U	Active
SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - B5111N	N/A	FDA UDI	U	Active
FlowPRA™ Control Beads	N/A	FDA UDI	N/A	Active
Class II Complement - 50 ml	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class II -DRB40103N	N/A	FDA UDI	U	Active
Fluorobeads™ B Lymphocyte – 100 Isolations	N/A	FDA UDI	Class I	Active
Micro SSP™ Generic HLA Class I and II ABDR DNA Typing Tray	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - C0409N	N/A	FDA UDI	U	Active
SeCore™ DPB1 Locus Sequencing Kit	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DQB1*03 High Resolution Kit	N/A	FDA UDI	U	Active
FluoroQuench Acridine Orange/Ethidium Bromide - 100ml	N/A	FDA UDI	Class I	Active
Micro SSP™ High Resolution HLA Class II DNA Typing Tray - DQA1	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*06	N/A	FDA UDI	U	Active
Terasaki HLA Class I ABC Tissue Typing Tray - (A)	N/A	FDA UDI	U	Active
LABScreen™ Single Antigen HLA Class II Supplement - Group 1	N/A	FDA UDI	U	Active

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