Cobas Ctng Qualitative Nucleic Acid Test for Use on the Cobas 6800/8800 Systems
Catalogue number 07460066190, listed by Roche Molecular Systems, Inc., United States, under Dna Probe, Nucleic Acid Amplification, Chlamydia. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
5510(k) clearances naming this product code
1recall
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 | Roche Molecular Systems, 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 | Specification developer, Manufacturer, Exporter |
| Record published | 2018-04-26 |
| Record revised | 2020-12-21 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07460066190 | 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 |
| Progensa | Hologic, Inc. | 1 |
| BD CTGCTV2 | Becton, Dickinson AND Company | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110923 | 2012-01-24 |
| K973707 | 1999-08-04 |
| K973718 | 1998-12-15 |
| K964507 | 1997-06-13 |
| K922906 | 1993-06-15 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-07-07 | Not classified | Other | An increased frequency of ‘blue foci’ that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection. | 2400 kits | 2005-01-07 |
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.