# One Lambda, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/one-lambda-inc>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000024901
- FDA FEI: 2024375
- DUNS: 118289289

## Figures

- Devices: 462
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0
- FDA establishments: 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 422, EUDAMED 108
- Device classes: FDA Unclassified 367, EU Class C 40, FDA Class I 17, FDA Class II 5
- EMDN [W01 Reagents](https://devicerts.com/categories/emdn/W01): 37 devices
- EMDN [W02 IVD instruments](https://devicerts.com/categories/emdn/W02): 3 devices

## Devices

The first 50 of 462, in the order of the canonical page, which lists them all.

- [AllType™ FASTplex™ NGS 11 Loci Kit - 96 (Box 1 of 2)](https://devicerts.com/devices/alltype-fastplex-ngs-11-loci-kit-96-box-1-of-2-all-fast11lf1c) · ref ALL-FAST11LF1C · Class C · EUDAMED · status: Active
- [FlowPRA™ Reagent Pack](https://devicerts.com/devices/flowpra-reagent-pack-fl-rp) · ref FL-RP · Class C · EUDAMED · status: Active
- [One Lambda™ HybriType™ HLA Plus Typing Flex Kit - 96](https://devicerts.com/devices/one-lambda-hybritype-hla-plus-typing-flex-kit-96-hyb18lf) · ref HYB18LF · Class C · EUDAMED · status: Active
- [AllType™ FASTplex™ NGS 11 Loci Kit – 48 (Box 1 of 2)](https://devicerts.com/devices/alltype-fastplex-ngs-11-loci-kit-48-box-1-of-2-all-fast11l1c) · ref ALL-FAST11L1C · Class C · EUDAMED · status: Active
- [AllType NGS Library Prep Kit](https://devicerts.com/devices/alltype-ngs-library-prep-kit-all-lib) · ref ALL-LIB · Class C · EUDAMED · status: Active
- [AllType™ FASTplex™ NGS 11 Kit (Box 2 of 2)](https://devicerts.com/devices/alltype-fastplex-ngs-11-kit-box-2-of-2-all-fast2c) · ref ALL-FAST2C · Class C · EUDAMED · status: Active
- [AllType™ NGS Index Kit](https://devicerts.com/devices/alltype-ngs-index-kit-all-ion) · ref ALL-ION · Class C · EUDAMED · status: Active
- [AllType™ NGS Index Flex Kit](https://devicerts.com/devices/alltype-ngs-index-flex-kit-all-flex) · ref ALL-FLEX · Class C · EUDAMED · status: Active
- [AllType™ Next Generation Sequencing (NGS) 11 Loci Amplification Kit](https://devicerts.com/devices/alltype-next-generation-sequencing-ngs-11-loci-amplification-all-11l) · ref ALL-11L · Class C · EUDAMED · status: Active
- [LABScreen™ Single Antigen HLA Class II ExPlex - Group 2](https://devicerts.com/devices/labscreen-single-antigen-hla-class-ii-explex-group-2-ls2aex02) · ref LS2AEX02 · Class C · EUDAMED · status: Active
- [uTYPE™ HLA Sequence Analysis Software](https://devicerts.com/devices/utype-hla-sequence-analysis-software-539992) · ref 539992 · Class C · EUDAMED · status: Active
- [HybriType™ HLA Plus Beads and Buffer Kit](https://devicerts.com/devices/hybritype-hla-plus-beads-and-buffer-kit-hyblib2) · ref HYBLIB2 · Class C · EUDAMED · status: Active
- [HybriType™ HLA Plus 18 Loci Flex Kit – 4 Enrichments](https://devicerts.com/devices/hybritype-hla-plus-18-loci-flex-kit-4-enrichments-hybhla3f) · ref HYBHLA3F · Class C · EUDAMED · status: Active
- [HybriType™ HLA Plus Library Prep Flex Kit – 96](https://devicerts.com/devices/hybritype-hla-plus-library-prep-flex-kit-96-hyblib1f) · ref HYBLIB1F · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABCDRDQB1 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abcdrdqb1-384-typing-kit-1554c) · ref 1554C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-B 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-b-384-typing-kit-2321c) · ref 2321C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-DRDQDP 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-drdqdp-384-typing-kit-1862c) · ref 1862C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABCDRDQB1 Typing Kit](https://devicerts.com/devices/linkseq-hla-abcdrdqb1-typing-kit-1054c-rlc) · ref 1054C-RLC · Class C · EUDAMED · status: Active
- [C1qScreen Negative Control Serum](https://devicerts.com/devices/c1qscreen-negative-control-serum-c1qs-nc) · ref C1QS-NC · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABC 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abc-384-typing-kit-1821c) · ref 1821C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-B27 Typing Kit](https://devicerts.com/devices/linkseq-hla-b27-typing-kit-8011c-sl) · ref 8011C-SL · Class C · EUDAMED · status: Active
- [SureTyper™](https://devicerts.com/devices/suretyper-sttpgrx) · ref STTPGRX · Class C · EUDAMED · status: Active
- [LinkSēq HLA-Single Locus ACDRDQDP 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-single-locus-acdrdqdp-384-typing-kit-2301c) · ref 2301C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-B\*57:01 Typing Kit](https://devicerts.com/devices/linkseq-hla-b-57-01-typing-kit-8020c-sl) · ref 8020C-SL · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABDR 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abdr-384-typing-kit-3332c) · ref 3332C · Class C · EUDAMED · status: Active
- [C1qScreen Class I Positive Control](https://devicerts.com/devices/c1qscreen-class-i-positive-control-c1qs-pc1) · ref C1QS-PC1 · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABCDRDQB1 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abcdrdqb1-384-typing-kit-1551c) · ref 1551C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABDR 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abdr-384-typing-kit-3331c) · ref 3331C · Class C · EUDAMED · status: Active
- [C1qScreen Class II Postive Control](https://devicerts.com/devices/c1qscreen-class-ii-postive-control-c1qs-pc2) · ref C1QS-PC2 · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABCDRDQB1 Typing Kit](https://devicerts.com/devices/linkseq-hla-abcdrdqb1-typing-kit-1054c-abs) · ref 1054C-ABS · Class C · EUDAMED · status: Active
- [LinkSēq HLA-B 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-b-384-typing-kit-2322c) · ref 2322C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abcdrdqdp-384-typing-kit-1575c) · ref 1575C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abcdrdqa1dqb1-384-typing-kit-1550c) · ref 1550C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-B\*57:01 Typing Kit](https://devicerts.com/devices/linkseq-hla-b-57-01-typing-kit-8020c-sr) · ref 8020C-SR · Class C · EUDAMED · status: Active
- [LinkSēq HLA-B27 Typing Kit](https://devicerts.com/devices/linkseq-hla-b27-typing-kit-8011c-sr) · ref 8011C-SR · Class C · EUDAMED · status: Active
- [TypeStream™ Visual Software version 3.2](https://devicerts.com/devices/typestream-visual-software-version-3-2-tsvpgr) · ref TSVPGR · Class C · EUDAMED · status: Active
- [LinkSēq HLA-DRDQDP 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-drdqdp-384-typing-kit-1861c) · ref 1861C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABC 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abc-384-typing-kit-1822c) · ref 1822C · Class C · EUDAMED · status: Active
- [LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit](https://devicerts.com/devices/linkseq-hla-abcdrdqdp-sabr-384-typing-kit-1580c) · ref 1580C · Class C · EUDAMED · status: Active
- [C1qScreen™](https://devicerts.com/devices/c1qscreen-c1q) · Class C · EUDAMED · status: Active
- [Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A\*29 SSPR1-29](https://devicerts.com/devices/micro-ssp-allele-specific-hla-class-i-dna-typing-tray-a-29-sspr1-29) · Unclassified · GUDID · status: Listed
- [Lambda Monoclonal Trays™ Set HLA Class I (A) LM144A](https://devicerts.com/devices/lambda-monoclonal-trays-set-hla-class-i-a-lm144a) · Unclassified · GUDID · status: Listed
- [LABType™ SSO Class I B7 Supplement Typing Test - 20 test RSO1S1T](https://devicerts.com/devices/labtype-sso-class-i-b7-supplement-typing-test-20-test-rso1s1t) · Unclassified · EUDAMED, GUDID · status: Active
- [LABType™ CWD Class II DRB1 Typing Test - Sample RSSOW2B1S](https://devicerts.com/devices/labtype-cwd-class-ii-drb1-typing-test-sample-rssow2b1s) · Unclassified · GUDID · status: Listed
- [LABType™ XR Class I C Locus Typing Test RSSOX1C](https://devicerts.com/devices/labtype-xr-class-i-c-locus-typing-test-rssox1c) · Unclassified · EUDAMED, GUDID · status: Active
- [Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1\*11 SSPR2-111](https://devicerts.com/devices/micro-ssp-allele-specific-hla-class-ii-dna-typing-tray-drb1-sspr2-111) · Unclassified · GUDID · status: Listed
- [SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit A15573](https://devicerts.com/devices/secore-drb1-locus-exon-2-and-3-sequencing-kit-a15573) · Unclassified · EUDAMED, GUDID · status: Active
- [AllSet+™ Gold SSP DRB5 High Resolution Kit 542120D](https://devicerts.com/devices/allset-gold-ssp-drb5-high-resolution-kit-542120d) · Unclassified · GUDID · status: Listed
- [Micro SSP™ AmbiStrips™ HLA Class I - C0320N SSPT1-A1](https://devicerts.com/devices/micro-ssp-ambistrips-hla-class-i-c0320n-sspt1-a1) · Unclassified · GUDID · status: Listed
- [Micro SSP™ HLA Class I C Locus Specific DNA Typing Tray SSP1C](https://devicerts.com/devices/micro-ssp-hla-class-i-c-locus-specific-dna-typing-tray-ssp1c) · Unclassified · GUDID · status: Listed

## EU certificates

- HX 2233216-1 · Quality management system · IVDR · notified body TÜV Rheinland LGA Products GmbH · issued 2025-10-29 · expires 2030-10-28 · status: issued

## Source and citation

- Cite as: One Lambda, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/one-lambda-inc (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/one-lambda-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/one-lambda-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.