Cordx Labs, Inc. (other, Alpharetta, GA): 2 new FDA device listings, incl. simple point-of-care device to directly detect sars-cov-2 viral target

Cordx Labs, Inc. (Alpharetta, Georgia): 2 new FDA device listings, incl. simple point-of-care device to directly detect sars-cov-2 viral target. Its amount of 2 is above the median of 1 (69th percentile). Dated 84 days ago, it serves as a historical benchmark. Score 50/100. 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: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 42 related GA DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentCordx Labs, Inc.
Owner / operatorCorDx Labs, Inc.
RoleOther
Establishment typesComplaint File Establishment per 21 CFR 820.198
LocationAlpharetta, GA, US
New listings2
DevicesSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings; Pad, Heating, Powered
Product codesQVF, IRT
Device classesClass II
Medical specialtiesMicrobiology, Physical Medicine
Brand namesCorDx Tyfast COVID-19 Ag Rapid Test Rx; Insect Bite Healer; @AL21 Insect Bite Healer; CorDx @AL21 Insect Bite Healer
First new listing2026-07-13
Latest new listing2026-08-12
FDA registration number3034405508
Registration expires2026-12-31
amount percentile69th of 2,570 (median 1, 2.0x median)
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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: 2026-08-12
  • 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: Cordx Labs, Inc. and 43 Georgia peers

  • Georgia DeviceEstablishmentPulse records like this one: 43
  • Cordx Labs, Inc.'s amount: 69th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Georgia peer: $8,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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50 / 100 Score

  • Class II or III devices: QMS and regulatory demands.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for Cordx Labs, Inc. in Alpharetta, Georgia?

Cordx Labs, Inc. (Alpharetta, GA), a other, added 2 FDA device listings between 2026-07-13 and 2026-08-12.

How does Cordx Labs, Inc. compare to other Georgia DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 84 days old; check the official source for later updates before acting.

Cordx Labs, Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Cordx Labs, Inc.Alpharetta, GA269th2026-08-12
Conmed CorporationUtica, NY377th2026-09-14
Euroimmun Us Inc.Mountain Lakes, NJ377th2026-09-10
Rohrer Aesthetics, Inc.Homewood, AL377th2026-09-09

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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.

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