RealTime
Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
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 | Abbott Molecular, Inc., United States |
|---|---|
| FDA product code | LSL |
| Device type | Dna-Reagents, Neisseria |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3390 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K140354 |
| Record published | 2016-09-01 |
| Record revised | 2022-03-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to -10 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 06L98-05 | In distribution | |
| 8L07-80 | In distribution | |
| 8L07-50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aptima | Hologic, Inc. | 11 |
| Aptima Combo 2® | Hologic, Inc. | 4 |
| 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 |
| Alinity m | Abbott Molecular, Inc. | 1 |
Showing 12 of 53. All products under Dna-Reagents, Neisseria
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140354 | 2014-05-09 |
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.