FDA device listing
AMP Rapid Test Cassette,MDA Rapid Test Cassette,Mescaline (MES) Rapid Test Cassette,Mescaline (MES) Rapid Test…
FDA device listing 2004797624 · Acro Biotech Inc.
Key facts
| Proprietary names | AMP Rapid Test Cassette,MDA Rapid Test Cassette,Mescaline (MES) Rapid Test Cassette,Mescaline (MES) Rapid Test Dipstick,Mescaline (MES) Rapid Test Panel,Tenamfetamine (MDA) Rapid Test Cassette,Tenamfetamine (MDA) Rapid Test Dipstick,Tenamfetamine (MDA) Rapid Test Panel |
|---|---|
| Owner/operator | Acro Biotech Inc. |
| Owner/operator number | 10043465 |
| Product codes | DNI |
| Device names | DNI - Liquid Chromatography, Amphetamine |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3100 |
| Review panels | Clinical Toxicology |
| 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 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