Cobas® Liat CT/NG
Catalogue number 10030933190, listed by Roche Molecular Systems, Inc., United States, under Dna-Reagents, Neisseria. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
6510(k) clearances naming this product code
2recalls on this code
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 | LSL |
| Device type | Dna-Reagents, Neisseria |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3390 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K240217 |
| Record published | 2026-02-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10030933190 | In distribution |
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 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 |
| 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 |
|---|---|
| K173887 | 2018-03-21 |
| K163184 | 2017-02-09 |
| K140887 | 2014-05-05 |
| K132270 | 2013-12-02 |
| K974503 | 1999-12-01 |
| K974342 | 1999-05-28 |
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. | 559 kits | 2005-01-07 |
| 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. | 1747 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.