Is this your brand? Sign in to claim ownership.

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 6 of 9

Device	Model / Reference	Registries	Class	Status
LABType™ HD Class I C Locus Typing Test - 1000 tests	N/A	FDA UDI	U	Active
SeCore™ DQB1 Locus 2AMP	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP A*03 High Resolution Kit	N/A	FDA UDI	U	Active
Lambda Antigen Tray™ Class I - 2 test tray	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*40	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*30	N/A	FDA UDI	U	Active
LABType™ HD Class I C Locus Typing Test - 20 tests	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*16/17/18	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*16	N/A	FDA UDI	U	Active
LABType™ HD Class I A Locus Typing Test	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*07	N/A	FDA UDI	U	Active
Terasaki HLA Class II Tissue Typing Tray	N/A	FDA UDI	U	Active
uTYPE™ Dx HLA Sequence Analysis Software	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DR Low Resolution Kit	N/A	FDA UDI	U	Active
Terasaki HLA Class I Asian Dry Tissue Typing Tray	N/A	FDA UDI	U	Active
Mouse IgG2b Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody - S	N/A	FDA UDI	U	Active
Lambda Antigen Tray™ Mixed Class I & II - Sample	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DPA1 Locus High Resolution Kit	N/A	FDA UDI	U	Active
Micro SSP™ HLA Class I A Locus Specific DNA Typing Tray	N/A	FDA UDI	U	Active
Lambda Monoclonal Trays™ Set HLA Class I (A, B) - 2-tray set	N/A	FDA UDI	U	Active
FlowPRA™ HLA Class I Screening Test - Sample	N/A	FDA UDI	N/A	Active
LABType™ SAPE Buffer	N/A	FDA UDI	U	Active
Micro SSP™ Generic HLA Class I and II DNA Typing Tray - ABDRDQ	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP B Locus High Resolution Kit	N/A	FDA UDI	U	Active
LABType™ CWD Class I C Locus Typing Test	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*08	N/A	FDA UDI	U	Active
LABType™ SAPE Buffer	N/A	FDA UDI	U	Active
LABType™ SSO Class I B Locus Typing Test - 20 tests	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DRB1*08/12 High Resolution Kit	N/A	FDA UDI	U	Active
PE-Conjugated Streptavidin	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*13	N/A	FDA UDI	U	Active
FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml	N/A	FDA UDI	Class I	Active
Lambda Cell Tray™ 72 T Cell Panel	N/A	FDA UDI	U	Active
FlowPRA™ Single Antigen HLA Class I - 3 Antibody Detection Test	N/A	FDA UDI	N/A	Active
Lyophilized Class I Complement	N/A	FDA UDI	U	Active
PE Conjugated Goat Anti-Human IgG	N/A	FDA UDI	U	Active
FlowPRA™ Class I Screening Beads	N/A	FDA UDI	N/A	Active
Micro SSP™ HLA Class I B Locus Specific DNA Typing Tray	N/A	FDA UDI	U	Active
LABType™ CWD Class I B Locus Typing Test - Sample	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*14	N/A	FDA UDI	U	Active
LABType™ HD Class I A Locus Typing Test - 20 tests	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - A6811N	N/A	FDA UDI	U	Active
Micro SSP™ Generic HLA Class II DNA Typing Tray - DRB Only	N/A	FDA UDI	U	Active
LABType™ SSO Class II DQA1/DQB1 Typing Test - 1000 tests	N/A	FDA UDI	U	Active
LABType™ SSO Class I B Locus Typing Test	N/A	FDA UDI	U	Active
Terasaki HLA Class I Dry Tissue Typing Tray	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP A*23/24 High Resolution Kit	N/A	FDA UDI	U	Active
Class I Complement - 5 ml	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*15	N/A	FDA UDI	U	Active
LABType™ HD Class I B Locus Typing Test - 1000 tests	N/A	FDA UDI	U	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.