FDA device listing
Acro Biotech Inc. HCG OTC Rapid Urine Test Midstream,HCG Pregnancy Rapid Test Midstream
FDA device listing 1130835122 · Acro Biotech Inc.
Key facts
| Proprietary names | Acro Biotech Inc. HCG OTC Rapid Urine Test Midstream,HCG Pregnancy Rapid Test Midstream |
|---|---|
| Owner/operator | Acro Biotech Inc. |
| Owner/operator number | 10043465 |
| Premarket submissions | K172512 |
| 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 | ACRO BIOTECH Inc. |
| Establishment registrations | 3005360469 |
| FEI numbers | 3005670738 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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