BTNX Inc. (repackager or relabeler, Pickering Ontario, CA): 11 new FDA device listings, incl. test, phencyclidine (pcp), over the counter
BTNX Inc. (Pickering Ontario, California): 11 new FDA device listings, incl. test, phencyclidine (pcp), over the counter. Its amount of 11 is top-decile (94th percentile of 2,570 records). Dated 48 days ago, it serves as a historical benchmark. Score 55/100. 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: 11 · 94th percentile of 2,570 DeviceEstablishmentPulse records · 11.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | BTNX Inc. |
| Role | Repackager or relabeler |
| Establishment types | Foreign Private Label Distributor; Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device |
| Location | Pickering Ontario, CA |
| New listings | 11 |
| Devices | Test, Phencyclidine (Pcp), Over The Counter; Test, Barbiturate, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Propoxyphene, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Opiates, Over The Counter; Test, Amphetamine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter; Test, Cannabinoid, Over The Counter |
| Product codes | NGM, PTH, NFY, QBF, NFV, NGG, NGL, NFT, QAW, NFW, PTG |
| Device classes | Class II, Unclassified |
| Medical specialties | Clinical Toxicology |
| Brand names | Rapid Response Multi-Drug Testing Cup; Rapid Response Home Drug Testing Cup |
| First new listing | 2026-09-18 |
| Latest new listing | 2026-09-18 |
| FDA registration number | 3003917514 |
| Registration expires | 2026-12-31 |
| amount percentile | 94th of 2,570 (median 1, 11.0x median) |
| Peer records CSV (284 CA 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: 2026-09-18
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CA first): Icu Medical, Inc. (specification developer, San Clemente, CA · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Cgbio USA, Inc. (repackager or relabeler, Irvine, CA) · Can Technomed Trading Ltd. (foreign exporter, Richmond Briti · Jmu Dental, Inc (repackager or relabeler, Fullerton, CA) · Browse all by state and category →
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: BTNX Inc. and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- BTNX Inc.'s amount: 94th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for BTNX Inc. in Pickering Ontario, California?
BTNX Inc. (Pickering Ontario, CA), a repackager or relabeler, added 11 FDA device listings on 2026-09-18.
How does BTNX Inc. compare to other California DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 11 is 11.0x the median of 1 across 2,570 records. It is 48 days old; check the official source for later updates before acting.
BTNX Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| BTNX Inc. | Pickering Ontario, CA | 11 | 94th | 2026-09-18 |
| Tpc Advanced Technology, Inc. | City Industry, CA | 4 | 83rd | 2026-09-28 |
| Jmu Dental, Inc | Fullerton, CA | 31 | 98th | 2026-09-29 |
| Cgbio USA, Inc. | Irvine, CA | 47 | 99th | 2026-10-13 |
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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.