Bacticard
BactiCard Neisseria 25TST/KT
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | JSX |
| Device type | Kit, Identification, Neisseria Gonorrhoeae |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R21110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel Inc | Remel, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K923566 | 1992-11-02 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N17985 | 1981-04-14 | GONOSTICON DRI-DOT | Organon LLC |
| P770002 | 1979-07-18 | GONOCOCCAL PILI ANTIBODY TEST | Bioquest |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.