FDA device listing
Group A Streptococcus Antigen Detection Kit (Immunochromatography),Group B Streptococcus Antigen Detection Kit…
FDA device listing 2068935034 · Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Key facts
| Proprietary names | Group A Streptococcus Antigen Detection Kit (Immunochromatography),Group B Streptococcus Antigen Detection Kit (Immunochromatography) |
|---|---|
| Owner/operator | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. |
| Owner/operator number | 10084191 |
| Product codes | GTY |
| Device names | GTY - Antigens, All Groups, Streptococcus Spp. |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3740 |
| Review panels | Microbiology |
| Registered establishments | JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD. |
| Establishment registrations | 3016733849 |
| FEI numbers | 3016733849 |
| Establishment operations | Manufacturer |
| 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