The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Mtb/rif Assay, Genexpert Dx, Genexpert Infinity-48, Genexpert Infinity-48s, Genexpert Infinity-80.
Device ID | K143302 |
510k Number | K143302 |
Device Name: | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 |
Classification | System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen |
Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
Contact | Kerry J Flom |
Correspondent | Pamela Johnson CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
Product Code | PEU |
CFR Regulation Number | 866.3373 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-17 |
Decision Date | 2015-02-12 |
Summary: | summary |