BD CTGCTV2
Catalogue number 443979, listed by Becton, Dickinson AND Company, United States, under Dna Probe, Nucleic Acid Amplification, Chlamydia. 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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | MKZ |
| Device type | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3120 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K210585 |
| Record published | 2022-06-08 |
| Record revised | 2024-08-28 (version 3) |
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 2 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 443979 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aptima® | Hologic, Inc. | 7 |
| Aptima Combo 2® | Hologic, Inc. | 4 |
| Alinity m | Abbott Molecular, Inc. | 2 |
| Multi-Collect | Abbott Molecular, Inc. | 1 |
| cobas z 480 | Roche Molecular Systems, Inc. | 1 |
| BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack | Becton, Dickinson AND Company | 1 |
| BD Molecular Swab Sample Buffer Tubes | Becton, Dickinson AND Company | 1 |
| cobas® PCR Media Uni Swab Sample Kit | Roche Molecular Systems, Inc. | 1 |
| BD Molecular LBC Sample Buffer Tubes | Becton, Dickinson AND Company | 1 |
| cobas Ctng Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 1 |
| Progensa | Hologic, Inc. | 1 |
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 |
|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2024-10-31 | Class II | Software design | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized | 18 units (12 US, 6 OUS) |
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.