One Lambda, Inc (other, Hennigsdorf Brandenburg, DE): 1 new FDA device listing, incl. human leukocyte antigen (hla) typing companion diagnostic test
One Lambda, Inc (Hennigsdorf Brandenburg, Delaware): 1 new FDA device listing, incl. human leukocyte antigen (hla) typing companion diagnostic test. Its amount of 1 is above the median of 1 (50th percentile). Dated 78 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 36 related DE DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | One Lambda, Inc |
| Owner / operator | One Lambda, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Hennigsdorf Brandenburg, DE |
| New listings | 1 |
| Devices | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test |
| Product codes | QUK |
| Device classes | Class II |
| Medical specialties | Immunology |
| Brand names | SeCore CDx HLA Sequencing System |
| First new listing | 2026-08-19 |
| Latest new listing | 2026-08-19 |
| FDA registration number | 3013058950 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (37 DE records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-19
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: One Lambda, Inc and 37 Delaware peers
- Delaware DeviceEstablishmentPulse records like this one: 37
- One Lambda, Inc's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $7,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
40 / 100 Score
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for One Lambda, Inc in Hennigsdorf Brandenburg, Delaware?
One Lambda, Inc (Hennigsdorf Brandenburg, DE), a other, added 1 FDA device listing on 2026-08-19.
How does One Lambda, Inc compare to other Delaware DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 78 days old; check the official source for later updates before acting.
One Lambda, Inc vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| One Lambda, Inc | Hennigsdorf Brandenburg, DE | 1 | 50th | 2026-08-19 |
| Conmed Corporation | Utica, NY | 3 | 77th | 2026-09-14 |
| Euroimmun Us Inc. | Mountain Lakes, NJ | 3 | 77th | 2026-09-10 |
| Rohrer Aesthetics, Inc. | Homewood, AL | 3 | 77th | 2026-09-09 |
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DeviceEstablishmentPulse: Other DeviceEstablishmentPulse: Foreign establishment DeviceEstablishmentPulse: records in Delaware
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.