Healgen Scientific LLC (specification developer, Houston, TX): 3 new FDA device listings, incl. kit, direct antigen, negative control
Healgen Scientific LLC (Houston, Texas): 3 new FDA device listings, incl. kit, direct antigen, negative control. Its amount of 3 is above the median of 1 (77th percentile). Dated 98 days ago, it serves as a historical benchmark. Score 85/100. 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: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 67 related TX DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Healgen Scientific LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Houston, TX, US |
| New listings | 3 |
| Devices | Kit, Direct Antigen, Negative Control; Kit, Direct Antigen, Positive Control; Control, Fecal Occult Blood |
| Product codes | MKA, MJZ, OSL |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, Hematology |
| Brand names | External Controls Healgen Rapid Check COVID-19/Flu A&B Antigen Test Pro |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-07-29 |
| FDA registration number | 3009238284 |
| Registration expires | 2026-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x median) |
| Peer records CSV (68 TX 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: 2026-07-29
- 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: Healgen Scientific LLC and 68 Texas peers
- Texas DeviceEstablishmentPulse records like this one: 68
- Healgen Scientific LLC's amount: 77th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $13,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Healgen Scientific LLC in Houston, Texas?
Healgen Scientific LLC (Houston, TX), a specification developer (outsources manufacturing), added 3 FDA device listings between 2026-06-09 and 2026-07-29.
How does Healgen Scientific LLC compare to other Texas DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 98 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Healgen Scientific LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Healgen Scientific LLC | Houston, TX | 3 | 77th | 2026-07-29 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Texas
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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.