Device Listing 1207753024

Listing Summary#

Listing key
1207753024
Premarket submission
K190441
Device
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
Applicant
Cepheid
Product code
QEP
Decision date
2019-05-23