# Wondfo USA Co., Ltd. (other, Bolingbrook, IL): 11 new FDA device listings, incl. enzyme immunoassay, phencyclidine

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Wondfo USA Co., Ltd. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Bolingbrook, IL, US |
| New listings | 11 |
| Devices | Enzyme Immunoassay, Phencyclidine; Test, Opiates, Over The Counter; Test, Barbiturate, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Methadone, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Propoxyphene, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter |
| Product codes | LCM, NGL, PTH, NFW, PTG, NFY, NGG, NFV, QBF, QAW, NFT |
| Device classes | Class II, Unclassified |
| Medical specialties | Clinical Toxicology |
| Brand names | SAFElife™ T-Dip Multi-Drug Urine Test Panel Dx; PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC20) |
| First new listing | 2026-08-05 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 3007606081 |
| Registration expires | 2027-12-31 |

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

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.