# BTNX Inc. (repackager or relabeler, Pickering Ontario, CA): 11 new FDA device listings, incl. test, phencyclidine (pcp), over the counter

**Score:** 55/100

| 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 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
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.