BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit
Swab Wet Female Endocervical
1manufacturer
2catalogue numbers in this listing
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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | LSL |
| Device type | Dna-Reagents, Neisseria |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3390 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K984631 |
| Record published | 2016-07-12 |
| Record revised | 2023-10-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Shelfpack of 100 |
| Distribution end date | 2022-06-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 220143 | Withdrawn | |
| 220142 | Withdrawn |
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 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2003-07-21 | Not classified | Other | Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results. | 1015 units | 2003-11-19 |
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.