Home › Device types › LSL
Dna-Reagents, Neisseria
FDA product code LSL · Class 2 · Microbiology
106
Registered devices
192
Adverse events
7
Recalls
45
510(k) clearances
Devices with this code
BD ProbeTec™ (GC) Qx Amplified DNA Assay — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems — Roche Molecular Systems, Inc.BD Viper™ Extraction Reagent and Lysis Trough — BECTON, DICKINSON AND COMPANYBD Molecular Urine Transport Kit — BECTON, DICKINSON AND COMPANYAptima Combo 2® — Hologic, Inc.BD ProbeTec™ ET Diluent (CT/GC) — BECTON, DICKINSON AND COMPANYdigene® HC2 CT/GC DNA Test — QIAGEN SCIENCES INC.cobas® PCR Media Uni Swab Sample Kit — Roche Molecular Systems, Inc.Aptima® — Hologic, Inc.cobas® liat CT/NG — Roche Molecular Systems, Inc.RealTime — ABBOTT MOLECULAR INC.BD Swab Diluent for the BD ProbeTec™ QX Amplified DNA Assays — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima Combo 2® — Hologic, Inc.BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays — BECTON, DICKINSON AND COMPANYAptima Combo 2® — Hologic, Inc.Progensa — Hologic, Inc.BD PT ET CT/GC Amplified DNA Assay Male Urethral Collection and Transport Kit — BECTON, DICKINSON AND COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-10-09 | Cepheid | Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using |
| 2015-07-27 | Cepheid | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expirat |
| 2015-07-27 | Cepheid | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expirat |
| 2005-01-10 | Becton Dickinson & Co. | An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections. |
| 2004-07-07 | Roche Molecular Systems Inc | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent durin |
| 2004-07-07 | Roche Molecular Systems Inc | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent durin |
| 2003-07-21 | Becton Dickinson & Co. | Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results. |
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