Cand-Tec
Candida Detection
1manufacturer
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Ramco Laboratories, Inc., United States |
|---|---|
| FDA product code | LHK |
| Device type | Antigen, Id, Candida Albicans |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| 510(k) | K823016 |
| Record published | 2019-03-26 |
| Record revised | 2024-09-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CO3/7 | In distribution | |
| CO3/1 | In distribution | |
| CO3/2 | In distribution | |
| CO3/5 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K823016 | 1982-12-28 |
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.