Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack
Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.
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 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PS-000715 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aptima | Hologic, Inc. | 11 |
| Aptima Combo 2® | Hologic, Inc. | 4 |
| RealTime | Abbott Molecular, Inc. | 3 |
| BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit | Becton, Dickinson AND Company | 2 |
| 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 |
| Visby Medical Sexual Health Click Test | Visby Medical, 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.