Visby Medical Sexual Health Click Test
Catalogue number 000175, listed by Visby Medical, Inc., United States, under Dna-Reagents, Neisseria. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Visby Medical, Inc., United States |
|---|---|
| FDA product code | LSL |
| Device type | Dna-Reagents, Neisseria |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3390 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200748 |
| Record published | 2021-09-15 |
| Record revised | 2023-06-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
| Distribution end date | 2023-06-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000175 | Withdrawn |
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| BD ProbeTec™ ET Diluent (CT/GC) | Becton, Dickinson AND Company | 2 |
| BD Viper™ System Remanufactured | Becton, Dickinson AND Company | 1 |
| cobas® liat CT, NG and MG control kit | Roche Molecular Systems, Inc. | 1 |
| cobas® liat CT/NG | Roche Molecular Systems, Inc. | 1 |
| BD Molecular Urine Transport Kit | Becton, Dickinson AND Company | 1 |
| BD ProbeTec™ ET Control Set | Becton, Dickinson AND Company | 1 |
| BD ProbeTec™ ET CT Reagent Pack | Becton, Dickinson AND Company | 1 |
| Alinity m | Abbott Molecular, Inc. | 1 |
Showing 12 of 53. All products under Dna-Reagents, Neisseria
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.