FDA device listing
Tuberculosis (TB) Rapid Test Cassette,Tuberculosis (TB) Rapid Test Dipstick
FDA device listing 1993002836 · Acro Biotech Inc.
Key facts
| Proprietary names | Tuberculosis (TB) Rapid Test Cassette,Tuberculosis (TB) Rapid Test Dipstick |
|---|---|
| Owner/operator | Acro Biotech Inc. |
| Owner/operator number | 10043465 |
| Product codes | GRT |
| Device names | GRT - Antiserum, Fluorescent, Mycobacterium Tuberculosis |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3370 |
| Review panels | Microbiology |
| 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