Panels › Microbiology › Product code LSL · Class 2
Dna-Reagents, Neisseria
Regulation 866.3390
0510(k)s in 12 months (45 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LSL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2017 | Cepheid Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157.
Is a qualitative in vitro real-time Terminated |
LSL | K121710 |
| Aug 20, 2015 | Cepheid Xpert CT/NG Urine Specimen Collection Kit
Part number GXCT/NGURINE-50;
Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseri Terminated |
LSL | K121710 |
| Aug 20, 2015 | Cepheid Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit:
Part number CT/NGSWAB-50;
Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, pres Terminated |
LSL | K121710 |
| Feb 3, 2005 | Becton Dickinson & Co. BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled Terminated |
LSL | None listed |
| Aug 19, 2004 | Roche Molecular Systems Inc Amplicor [3] AV-HRP, Avidin-HRP Horseradish Peroxidase) BGG Conjugate.
Kit: AMPLICOR NG Detection Kit, Export IVD/CE. Terminated |
LSL | None listed |
| Aug 19, 2004 | Roche Molecular Systems Inc Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.)
Kit: Amplicor CT/NG NG Detection Kit Terminated |
LSL | K974503 |
| Aug 20, 2003 | Becton Dickinson & Co. Becton Dickinson's ProbeTec (tm) ET Instrument Terminated |
LSL | K984631 |
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