One Lambda, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000024901 FEI 2024375
- Devices
- 462
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
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.
Catalogue
Search and filter all 462 devicesShowing 101-150 of 462
Company details
- EUDAMED SRN
- US-MF-000024901
- FDA FEI number
- 2024375
- DUNS number
- 118289289
- EUDAMED status
- Active
- EUDAMED registered name
- One Lambda, Inc.
- Registered address
- 22801, Roscoe Blvd., 91304, West Hills, United States
- Phone
- +(747)-494-1000
- PRRC contact
- Sheryl Skinner
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 28 Oct 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HX 2233216-1 Active
Quality management system EU IVDR
- Issued
- 29 Oct 2025
- Expires
- 28 Oct 2030
FDA establishments
- One Lambda, Inc Hennigsdorf Brandenburg · DE FEI 3013058950
Frequently asked questions
How many devices does ONE LAMBDA, INC. have in the registry?
The registry currently lists 462 devices for ONE LAMBDA, INC.. Devices recorded under merged duplicate company entries are counted once.
What EUDAMED certificates are recorded for ONE LAMBDA, INC.?
EUDAMED lists 1 certificate for ONE LAMBDA, INC. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 29 Oct 2025.
Which FDA establishments are linked to ONE LAMBDA, INC.?
1 FDA establishment is linked to ONE LAMBDA, INC. in the registry; they are listed on the company page.