{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "One Lambda, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/one-lambda-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/one-lambda-inc",
    "json_url": "https://devicerts.com/manufacturers/one-lambda-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/one-lambda-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "manufacturer": {
    "name": "One Lambda, Inc.",
    "url": "https://devicerts.com/manufacturers/one-lambda-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000024901"
      },
      {
        "label": "FDA FEI",
        "value": "2024375"
      },
      {
        "label": "DUNS",
        "value": "118289289"
      }
    ],
    "summary": "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.",
    "noindex": false
  },
  "counts": {
    "devices": 462,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 422
      },
      {
        "registry": "EUDAMED",
        "devices": 108
      }
    ],
    "device_classes": [
      {
        "class": "FDA Unclassified",
        "devices": 367
      },
      {
        "class": "EU Class C",
        "devices": 40
      },
      {
        "class": "FDA Class I",
        "devices": 17
      },
      {
        "class": "FDA Class II",
        "devices": 5
      }
    ],
    "top_emdn_categories": [
      {
        "code": "W01",
        "name": "Reagents",
        "url": "https://devicerts.com/categories/emdn/W01",
        "devices": 37
      },
      {
        "code": "W02",
        "name": "IVD instruments",
        "url": "https://devicerts.com/categories/emdn/W02",
        "devices": 3
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 462,
    "all_devices_url": "https://devicerts.com/manufacturers/one-lambda-inc",
    "items": [
      {
        "name": "AllType™ FASTplex™ NGS 11 Loci Kit - 96 (Box 1 of 2)",
        "url": "https://devicerts.com/devices/alltype-fastplex-ngs-11-loci-kit-96-box-1-of-2-all-fast11lf1c",
        "model_reference": "ALL-FAST11LF1C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FlowPRA™ Reagent Pack",
        "url": "https://devicerts.com/devices/flowpra-reagent-pack-fl-rp",
        "model_reference": "FL-RP",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "One Lambda™ HybriType™ HLA Plus Typing Flex Kit - 96",
        "url": "https://devicerts.com/devices/one-lambda-hybritype-hla-plus-typing-flex-kit-96-hyb18lf",
        "model_reference": "HYB18LF",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AllType™ FASTplex™ NGS 11 Loci Kit – 48 (Box 1 of 2)",
        "url": "https://devicerts.com/devices/alltype-fastplex-ngs-11-loci-kit-48-box-1-of-2-all-fast11l1c",
        "model_reference": "ALL-FAST11L1C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AllType NGS Library Prep Kit",
        "url": "https://devicerts.com/devices/alltype-ngs-library-prep-kit-all-lib",
        "model_reference": "ALL-LIB",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AllType™ FASTplex™ NGS 11 Kit (Box 2 of 2)",
        "url": "https://devicerts.com/devices/alltype-fastplex-ngs-11-kit-box-2-of-2-all-fast2c",
        "model_reference": "ALL-FAST2C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AllType™ NGS Index Kit",
        "url": "https://devicerts.com/devices/alltype-ngs-index-kit-all-ion",
        "model_reference": "ALL-ION",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AllType™ NGS Index Flex Kit",
        "url": "https://devicerts.com/devices/alltype-ngs-index-flex-kit-all-flex",
        "model_reference": "ALL-FLEX",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AllType™ Next Generation Sequencing (NGS) 11 Loci Amplification Kit",
        "url": "https://devicerts.com/devices/alltype-next-generation-sequencing-ngs-11-loci-amplification-all-11l",
        "model_reference": "ALL-11L",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LABScreen™ Single Antigen HLA Class II ExPlex - Group 2",
        "url": "https://devicerts.com/devices/labscreen-single-antigen-hla-class-ii-explex-group-2-ls2aex02",
        "model_reference": "LS2AEX02",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "uTYPE™ HLA Sequence Analysis Software",
        "url": "https://devicerts.com/devices/utype-hla-sequence-analysis-software-539992",
        "model_reference": "539992",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HybriType™ HLA Plus Beads and Buffer Kit",
        "url": "https://devicerts.com/devices/hybritype-hla-plus-beads-and-buffer-kit-hyblib2",
        "model_reference": "HYBLIB2",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HybriType™ HLA Plus 18 Loci Flex Kit – 4 Enrichments",
        "url": "https://devicerts.com/devices/hybritype-hla-plus-18-loci-flex-kit-4-enrichments-hybhla3f",
        "model_reference": "HYBHLA3F",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HybriType™ HLA Plus Library Prep Flex Kit – 96",
        "url": "https://devicerts.com/devices/hybritype-hla-plus-library-prep-flex-kit-96-hyblib1f",
        "model_reference": "HYBLIB1F",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABCDRDQB1 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abcdrdqb1-384-typing-kit-1554c",
        "model_reference": "1554C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-B 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-b-384-typing-kit-2321c",
        "model_reference": "2321C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-DRDQDP 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-drdqdp-384-typing-kit-1862c",
        "model_reference": "1862C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABCDRDQB1 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abcdrdqb1-typing-kit-1054c-rlc",
        "model_reference": "1054C-RLC",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "C1qScreen Negative Control Serum",
        "url": "https://devicerts.com/devices/c1qscreen-negative-control-serum-c1qs-nc",
        "model_reference": "C1QS-NC",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABC 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abc-384-typing-kit-1821c",
        "model_reference": "1821C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-B27 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-b27-typing-kit-8011c-sl",
        "model_reference": "8011C-SL",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureTyper™",
        "url": "https://devicerts.com/devices/suretyper-sttpgrx",
        "model_reference": "STTPGRX",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-Single Locus ACDRDQDP 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-single-locus-acdrdqdp-384-typing-kit-2301c",
        "model_reference": "2301C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-B*57:01 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-b-57-01-typing-kit-8020c-sl",
        "model_reference": "8020C-SL",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABDR 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abdr-384-typing-kit-3332c",
        "model_reference": "3332C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "C1qScreen Class I Positive Control",
        "url": "https://devicerts.com/devices/c1qscreen-class-i-positive-control-c1qs-pc1",
        "model_reference": "C1QS-PC1",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABCDRDQB1 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abcdrdqb1-384-typing-kit-1551c",
        "model_reference": "1551C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABDR 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abdr-384-typing-kit-3331c",
        "model_reference": "3331C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "C1qScreen Class II Postive Control",
        "url": "https://devicerts.com/devices/c1qscreen-class-ii-postive-control-c1qs-pc2",
        "model_reference": "C1QS-PC2",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABCDRDQB1 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abcdrdqb1-typing-kit-1054c-abs",
        "model_reference": "1054C-ABS",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-B 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-b-384-typing-kit-2322c",
        "model_reference": "2322C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abcdrdqdp-384-typing-kit-1575c",
        "model_reference": "1575C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abcdrdqa1dqb1-384-typing-kit-1550c",
        "model_reference": "1550C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-B*57:01 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-b-57-01-typing-kit-8020c-sr",
        "model_reference": "8020C-SR",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-B27 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-b27-typing-kit-8011c-sr",
        "model_reference": "8011C-SR",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "TypeStream™ Visual Software version 3.2",
        "url": "https://devicerts.com/devices/typestream-visual-software-version-3-2-tsvpgr",
        "model_reference": "TSVPGR",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-DRDQDP 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-drdqdp-384-typing-kit-1861c",
        "model_reference": "1861C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABC 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abc-384-typing-kit-1822c",
        "model_reference": "1822C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit",
        "url": "https://devicerts.com/devices/linkseq-hla-abcdrdqdp-sabr-384-typing-kit-1580c",
        "model_reference": "1580C",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "C1qScreen™",
        "url": "https://devicerts.com/devices/c1qscreen-c1q",
        "model_reference": null,
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*29 SSPR1-29",
        "url": "https://devicerts.com/devices/micro-ssp-allele-specific-hla-class-i-dna-typing-tray-a-29-sspr1-29",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lambda Monoclonal Trays™ Set HLA Class I (A) LM144A",
        "url": "https://devicerts.com/devices/lambda-monoclonal-trays-set-hla-class-i-a-lm144a",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LABType™ SSO Class I B7 Supplement Typing Test - 20 test RSO1S1T",
        "url": "https://devicerts.com/devices/labtype-sso-class-i-b7-supplement-typing-test-20-test-rso1s1t",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LABType™ CWD Class II DRB1 Typing Test - Sample RSSOW2B1S",
        "url": "https://devicerts.com/devices/labtype-cwd-class-ii-drb1-typing-test-sample-rssow2b1s",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LABType™ XR Class I C Locus Typing Test RSSOX1C",
        "url": "https://devicerts.com/devices/labtype-xr-class-i-c-locus-typing-test-rssox1c",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*11 SSPR2-111",
        "url": "https://devicerts.com/devices/micro-ssp-allele-specific-hla-class-ii-dna-typing-tray-drb1-sspr2-111",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit A15573",
        "url": "https://devicerts.com/devices/secore-drb1-locus-exon-2-and-3-sequencing-kit-a15573",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AllSet+™ Gold SSP DRB5 High Resolution Kit 542120D",
        "url": "https://devicerts.com/devices/allset-gold-ssp-drb5-high-resolution-kit-542120d",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Micro SSP™ AmbiStrips™ HLA Class I - C0320N SSPT1-A1",
        "url": "https://devicerts.com/devices/micro-ssp-ambistrips-hla-class-i-c0320n-sspt1-a1",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Micro SSP™ HLA Class I C Locus Specific DNA Typing Tray SSP1C",
        "url": "https://devicerts.com/devices/micro-ssp-hla-class-i-c-locus-specific-dna-typing-tray-ssp1c",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "HX 2233216-1",
      "type": "Quality management system",
      "legislation": "IVDR",
      "notified_body": "TÜV Rheinland LGA Products GmbH",
      "issued": "2025-10-29",
      "expires": "2030-10-28",
      "status": "issued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}