FDA device listing
Amazon Digital Pregnancy Test,Amazon Digital Wide-Tip Pregnancy Test,CareOne Digital Wide-Tip Pregnancy Test,Clearblue…
FDA device listing 1189705454 · SPD SWISS PRECISION DIAGNOSTICS GMBH
Key facts
| Proprietary names | Amazon Digital Pregnancy Test,Amazon Digital Wide-Tip Pregnancy Test,CareOne Digital Wide-Tip Pregnancy Test,Clearblue Digital Pregnancy Test,CVS Health Digital & Early Result Pregnancy Test Kit,CVS HEALTH DIGITAL & ONE STEP PREGNANCY TEST KIT,CVS HEALTH DIGITAL PREGNANCY TEST,CVS Health Digital Wide-Tip Pregnancy Test,CVS HEALTH DOUBLE TEST PREGNANCY TESTS,CVS HEALTH WIDE-TIP TRIPLE TEST… |
|---|---|
| Owner/operator | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| Owner/operator number | 9102922 |
| Premarket submissions | K060128 |
| Product codes | LCX |
| Device names | LCX - Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1155 |
| Review panels | Clinical Chemistry |
| Registered establishments | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| Establishment registrations | 3006635320 |
| FEI numbers | 3006635320 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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