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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 3 of 9

Device	Model / Reference	Registries	Class	Status
Lambda Antigen Tray™ Single Antigen Class I	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - AmB5619N	N/A	FDA UDI	U	Active
Terasaki HLA-C Locus Tissue Typing Tray	n/a	FDA UDI	U	Active
LABType™ CWD Class I DRB1 Locus Typing	N/A	FDA UDI	N/A	Active
Micro SSP™ Null Allele Specific HLA Class I DNA Typing Tray	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DRB1*13 High Resolution Kit	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DQB1 Locus High Resolution Kit	N/A	FDA UDI	U	Active
LABType™ CWD Class I C Locus Typing Test - Sample	N/A	FDA UDI	U	Active
SeCore™ B Locus Sequencing Kit, Single Amplification System	N/A	EUDAMEDFDA UDI	U	Active
AllSet+™ Gold SSP DQA1 Locus High Resolution Kit	N/A	FDA UDI	U	Active
LABType™ CWD Class I B Locus Typing Test	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ Negative Control	N/A	FDA UDI	U	Active
Lambda Monoclonal Trays™ HLA Class I (Oriental)	N/A	FDA UDI	U	Active
LABType™ SSO Class I Exon 4-7 Supplement Typing Test	N/A	FDA UDI	U	Active
Terasaki HLA-C Locus Tissue Typing Tray	n/a	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*32	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*18	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - AmB5201	N/A	FDA UDI	U	Active
FlowPRA™ Single Antigen HLA Class II Supplement - 5 Antibody Detection Test	N/A	FDA UDI	N/A	Active
Phosphate Buffered Saline/Citrate Reagent	N/A	FDA UDI	Class I	Active
AllSet+™ Gold SSP B*35 High Resolution Kit	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*15	N/A	FDA UDI	U	Active
Micro SSP™ High Resolution HLA Class II DNA Typing Tray - DPA1/DPB1	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*26	N/A	FDA UDI	U	Active
SeCore™ CDx HLA A Locus Sequencing Kit	SECCDX-A	FDA UDI	Class II	Active
Terasaki HLA Class I ABC Tissue Typing Tray - (B)	N/A	FDA UDI	U	Active
Terasaki HLA-A Locus Supplement Tissue Typing Tray	n/a	FDA UDI	U	Active
HLA Fusion™ Software (IVD)	N/A	FDA UDI	U	Active
Mouse IgG2b Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody	N/A	FDA UDI	U	Active
LABType™ SSO Class I B Locus Typing Test - 1000 tests	N/A	FDA UDI	U	Active
LABType™ SSO Class II DRB3, 4, 5 Typing Test - Sample	N/A	FDA UDI	U	Active
FlowPRA™ Single Antigen HLA Class I - 1 Antibody Detection Test	N/A	FDA UDI	N/A	Active
AllSet+™ Gold SSP DRB1*11 High Resolution Kit	N/A	FDA UDI	U	Active
LABType™ SAPE Buffer	N/A	FDA UDI	U	Active
Lambda Monoclonal Trays™ HLA Class I (Black)	N/A	FDA UDI	U	Active
LABType™ SSO Class II DPA1/DPB1 Typing Test - Sample	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - B27+ B81	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DRB1*04 High Resolution Kit	N/A	FDA UDI	U	Active
Micro SSP™ Generic HLA Class II DNA Typing Tray - DQB1 Only	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DPB1 Locus High Resolution Kit	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP B*22 High Resolution Kit	N/A	FDA UDI	U	Active
LABType™ SAPE Buffer	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - AmB46	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DQ Low Resolution Kit	N/A	FDA UDI	U	Active
Adsorb Out	N/A	FDA UDI	Class I	Active
FlowPRA™ Single Antigen HLA Class I Supplement - 10 Antibody Detection Test	N/A	FDA UDI	N/A	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*38/39	N/A	FDA UDI	U	Active
Lambda Cell Tray™ 30 T Cell Panel	N/A	FDA UDI	U	Active
LABType™ CWD Class I A Locus Typing Test	N/A	FDA UDI	N/A	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*03	N/A	FDA UDI	U	Active

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