One Lambda, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000024901 FEI 2024375
One Lambda, Inc. is a medical device manufacturer based in the United States, with 462 devices listed in FDA GUDID and EUDAMED (FDA Unclassified, Class I and Class II; EU Class C) as of 14 Nov 2026.
- Devices
- 462
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 422
- EUDAMED 108
- Device classes
- FDA Unclassified 367
- EU Class C 40
- FDA Class I 17
- FDA Class II 5
- Top EMDN categories
- Identifiers
- EUDAMED SRN US-MF-000024901
- FDA FEI 2024375
- DUNS 118289289
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
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 1-50 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.
Which registries list ONE LAMBDA, INC.'s devices?
Among its 50 most recently registered devices, ONE LAMBDA, INC. has devices listed in EUDAMED (43 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ONE LAMBDA, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ONE LAMBDA, INC.'s devices are IVDR Class C. Each device page shows its own class and authorisation.
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.
What are the newest devices from ONE LAMBDA, INC. in the registry?
The most recently registered devices listed for ONE LAMBDA, INC. include AllType™ FASTplex™ NGS 11 Loci Kit - 96 (Box 1 of 2), FlowPRA™ Reagent Pack, One Lambda™ HybriType™ HLA Plus Typing Flex Kit - 96 and AllType™ FASTplex™ NGS 11 Loci Kit – 48 (Box 1 of 2).
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.