FDA device listing
QuidelOrtho QKVUE+ HCG SERUM/URINE 30 TEST KIT,QuidelOrtho QKVUE+ HCG SERUM/URINE 90 TEST KIT,QuidelOrtho QUICKVUE HCG…
FDA device listing 1516131816 · ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V.
Key facts
| Proprietary names | QuidelOrtho QKVUE+ HCG SERUM/URINE 30 TEST KIT,QuidelOrtho QKVUE+ HCG SERUM/URINE 90 TEST KIT,QuidelOrtho QUICKVUE HCG COMBO 50 TEST KIT,QuidelOrtho QUICKVUE™ hCG Combo Test,QuidelOrtho QUICKVUE HCG URINE 25 TEST KIT,QuidelOrtho QUICKVUE HCG URINE 25 TEST KIT (INTL),QuidelOrtho QUICKVUE™ hCG Urine Test |
|---|---|
| Owner/operator | ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V. |
| Owner/operator number | 10082574 |
| Product codes | KHO |
| Device names | KHO - Fluorometer, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2560 |
| Review panels | Clinical Chemistry |
| Registered establishments | ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V. |
| Establishment registrations | 3012516456 |
| FEI numbers | 3012516456 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database