Dna-Reagents, Chlamydia
FDA product code LSK · Class I (low risk) · 21 CFR 866.3120 · Microbiology
8510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092704 | Abbott Realtime Ct/Ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…LSK · Traditional | Abbott Molecular, Inc. | 05/28/2010SE |
| K010891 | Modification to Hybrid Capture II Ct/Gc Test, Model 03M90-01LSK · Traditional | Digene Corp. | 09/25/2001SE |
| K010892 | Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01LSK · Traditional | Digene Corp. | 09/24/2001SE |
| K990023 | Hybrid Capture II Ct-Id TestLSK · Traditional | Digene Corp. | 10/25/1999SE |
| K920302 | Pace 2 Chlamydia Trachomatis Probe Confirm AssayLSK · Traditional | Gen-Probe, Inc. | 04/06/1994SE |
| K920378 | Pace 2 System for Chlamydia TrachomatisLSK · Traditional | Gen-Probe, Inc. | 04/29/1992SE |
| K874878 | Gen-Probe(R) Pace(Tm) System Chlamydia TrachomatisLSK · Traditional | Gen-Probe, Inc. | 12/29/1987SE |
| K871878 | Rapid Diagnostic System for Chlamydia TrachomatisLSK · Traditional | Gen-Probe, Inc. | 10/28/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1397-2011 | Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des…Internal testing identified the potential of under filled and over filled enzyme reagent vials which may… | Abbott Molecular | 12/20/2010Terminated |