Progensa
Catalogue number ASSAY FLUIDS KIT, listed by Hologic, Inc., United States, under Dna Probe, Nucleic Acid Amplification, Chlamydia. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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 | Hologic, Inc., United States |
|---|---|
| FDA product code | MKZ |
| Device type | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3120 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2014-09-17 |
| Record revised | 2024-06-27 (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 |
| Distribution end date | 2021-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASSAY FLUIDS KIT | Withdrawn |
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 |
| BD CTGCTV2 | Becton, Dickinson AND Company | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230451 | 2023-11-16 |
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.