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 1 of 9

Device	Model / Reference	Registries	Class	Status
LinkSēq HLA-ABCDRDQB1 384 Typing Kit	1554C	EUDAMED	Class C	Active
LinkSēq HLA-B 384 Typing Kit	2321C	EUDAMED	Class C	Active
LinkSēq HLA-DRDQDP 384 Typing Kit	1862C	EUDAMED	Class C	Active
LinkSēq HLA-ABCDRDQB1 Typing Kit	1054C-RLC	EUDAMED	Class C	Active
C1qScreen Negative Control Serum	C1QS-NC	EUDAMED	Class C	Active
LinkSēq HLA-ABC 384 Typing Kit	1821C	EUDAMED	Class C	Active
LinkSēq HLA-B27 Typing Kit	8011C-SL	EUDAMED	Class C	Active
SureTyper™	STTPGRX	EUDAMED	Class C	Active
LinkSēq HLA-Single Locus ACDRDQDP 384 Typing Kit	2301C	EUDAMED	Class C	Active
LinkSēq HLA-B*57:01 Typing Kit	8020C-SL	EUDAMED	Class C	Active
LinkSēq HLA-ABDR 384 Typing Kit	3332C	EUDAMED	Class C	Active
C1qScreen Class I Positive Control	C1QS-PC1	EUDAMED	Class C	Active
LinkSēq HLA-ABCDRDQB1 384 Typing Kit	1551C	EUDAMED	Class C	Active
LinkSēq HLA-ABDR 384 Typing Kit	3331C	EUDAMED	Class C	Active
C1qScreen Class II Postive Control	C1QS-PC2	EUDAMED	Class C	Active
LinkSēq HLA-ABCDRDQB1 Typing Kit	1054C-ABS	EUDAMED	Class C	Active
LinkSēq HLA-B 384 Typing Kit	2322C	EUDAMED	Class C	Active
LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit	1575C	EUDAMED	Class C	Active
LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit	1550C	EUDAMED	Class C	Active
LinkSēq HLA-B*57:01 Typing Kit	8020C-SR	EUDAMED	Class C	Active
LinkSēq HLA-B27 Typing Kit	8011C-SR	EUDAMED	Class C	Active
TypeStream™ Visual Software version 3.2	TSVPGR	EUDAMED	Class C	Active
LinkSēq HLA-DRDQDP 384 Typing Kit	1861C	EUDAMED	Class C	Active
LinkSēq HLA-ABC 384 Typing Kit	1822C	EUDAMED	Class C	Active
LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit	1580C	EUDAMED	Class C	Active
C1qScreen™	C1Q	EUDAMED	Class C	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*29	N/A	FDA UDI	U	Active
Lambda Monoclonal Trays™ Set HLA Class I (A)	N/A	FDA UDI	U	Active
LABType™ SSO Class I B7 Supplement Typing Test - 20 test	N/A	FDA UDI	U	Active
LABType™ CWD Class II DRB1 Typing Test - Sample	N/A	FDA UDI	U	Active
LABType™ XR Class I C Locus Typing Test	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*11	N/A	FDA UDI	U	Active
SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DRB5 High Resolution Kit	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class I - C0320N	N/A	FDA UDI	U	Active
Micro SSP™ HLA Class I C Locus Specific DNA Typing Tray	N/A	FDA UDI	U	Active
LABType™ XR Class I B Locus Typing Test - Sample	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*08	N/A	FDA UDI	U	Active
SeCore™ DRB1 Locus Sequencing Kit	N/A	FDA UDI	U	Active
Lambda Antigen Tray™ Class I - 1 test tray	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP DQB1*05 High Resolution Kit	N/A	FDA UDI	U	Active
PE - Conjugated Goat Anti-Human IgG (100X)	N/A	FDA UDI	U	Active
LABScreen™ Single Antigen HLA Class II ExPlex	N/A	FDA UDI	U	Active
Micro SSP™ High Resolution HLA Class II DNA Typing Tray	N/A	FDA UDI	U	Active
AllSet+™ Gold SSP B*51/52 High Resolution Kit	N/A	FDA UDI	U	Active
FlowPRA™ Single Antigen HLA Class I Antibody Detection Test	N/A	FDA UDI	N/A	Active
Fluorobeads™ B Lymphocyte – 25 Isolations	N/A	FDA UDI	Class I	Active
LABType™ XR Class I A Locus Typing Test - Sample	N/A	FDA UDI	U	Active
Micro SSP™ AmbiStrips™ HLA Class II -DRB50110N	N/A	FDA UDI	U	Active
Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*11	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.