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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 2 of 9

Device	Model / Reference	Registries	Class	Status
Micro SSP™ AmbiStrips™ HLA Class I - AmB1836	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - B27 Combo	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP B Low Resolution Kit	N/A	FDA UDI	U	Active
Lyophilized Class II Complement	N/A	FDA UDI	N/A	Active
LABScreen™ Single Antigen HLA Class II - Group 1	N/A	FDA UDI	U	Active
Class II Complement - 5 ml	N/A	FDA UDI	U	Active
LABType™ SSO Class I A Locus Typing Test - 20 tests	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - B1501N	N/A	FDA UDI	U	Active
Micro SSP™ Gel System - 108 Wells	N/A	FDA UDI	Class I	Active
LABType™ SSO MICA	N/A	FDA UDI	U	Active
Terasaki HLA Class I Tissue Typing Tray Set	N/A	FDA UDI	U	Active
SeCore™ B Locus Sequencing Kit, Single Amplification	N/A	EUDAMEDFDA UDI	U	Active
LABScreen™ Single Antigen HLA Class I ExPlex	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*44	N/A	FDA UDI	U	Active
SeCore™ GSSP Kit	N/A	FDA UDI	U	Active
LABType™ SSO Class I B7 Supplement Typing Test	N/A	FDA UDI	U	Active
LABType™ SSO Class I Exon 4-7 Supplement Typing Test - 20 tests	N/A	FDA UDI	U	Active
LABType™ XR Class I B Locus Typing Test	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DQB1*02/04 High Resolution Kit	N/A	FDA UDI	U	Active
Lambda Monoclonal Trays™ First HLA Class II - 60 well	N/A	FDA UDI	U	Active
Lympho-Kwik T Lymphocyte, 50 isolations	N/A	FDA UDI	Class I	Active
FlowPRA™ Negative Control	N/A	FDA UDI	N/A	Active
Lambda Monoclonal Trays™ Set HLA Class I (B)	N/A	FDA UDI	U	Active
Terasaki HLA-ABC First Tissue Typing Tray	N/A	FDA UDI	U	Active
LABType™ SSO Class I A Locus Typing Test - Sample	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*03	N/A	FDA UDI	U	Active
SeCore™ CDx HLA GSSP Kit	SECCDX-GSSP	FDA UDI	Class II	Active
Micro SSP™ AmbiStrips™ HLA Class I - A0101N	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*46/67/81/82	N/A	FDA UDI	U	Active
Micro SSP™ Japanese HLA Class I and II A, B, C, DRB, DQB1 DNA Typing Tray	N/A	FDA UDI	U	Active
SeCore™ B Locus Sequencing Kit - Group Specific Set	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*33	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DQB1*06 High Resolution Kit	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - AmB4803	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*53	N/A	FDA UDI	U	Active
SeCore™ C Locus Sequencing Kit	N/A	FDA UDI	U	Active
FlowPRA™ Single Antigen HLA Class II - 1 Antibody Detection Test	N/A	FDA UDI	N/A	Active
Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*01	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class II -DRB50108N	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*15	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DRB3 High Resolution Kit	N/A	FDA UDI	U	Active
Terasaki HLA-B7/40 Supplement Tissue Typing Tray	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*48	N/A	FDA UDI	U	Active
LABType™ SSO Class II DQA1/DQB1 Typing Test - 20 tests	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP ABDRDQ Low Resolution Kit	N/A	FDA UDI	U	Active
Terasaki HLA Class I Tissue Typing Tray Set (A)	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™ AmbiStrips™ HLA Class II -DRB40103N	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*47	N/A	FDA UDI	U	Active
LABType™ CWD Class I C Locus Typing Test	N/A	FDA UDI	U	Active

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