Lyra Direct C.difficile Assay

FDA registration

Ortho-Clinical Diagnostics, Inc.·2 products·🇺🇸 United States

NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Panther Fusion®

FDA UDI

Hologic, Inc.·15420045509306·The Panther Fusion® Paraflu assay is a multiple...

Verigene® Processor SP (Refurbished)

FDA UDI

LUMINEX CORPORATION·00840487101490·The Verigene® Processor SP is an instrument whi...

m2000

FDA UDI

ABBOTT MOLECULAR INC.·00884999006539·Optical Adhesive Cover

GeneXpert Dx System

FDA UDI

CEPHEID·07332940003357·XPERT, GENEXPERT DX SYSTEM

Gastrointestinal Pathogen Panel (GPP) Kit

FDA UDI

APPLIED BIOCODE, INC.·00851034007011·In-vitro multiplex assay used with the Biocode ...

Verigene® Reader (Refurbished)

FDA UDI

LUMINEX CORPORATION·00840487101476·The Verigene® Reader is the central control of ...

BioCode MDx 3000

FDA UDI

APPLIED BIOCODE, INC.·00851034007004·The BioCode MDx 3000 is an automated molecular ...

GeneXpert Dx System

FDA UDI

CEPHEID·07332940006709·XPERT, GENEXPERT DX SYSTEM

ID NOW Strep A 2 Control Swab Kit

FDA UDI

Alere Scarborough, Inc.·10811877010583·Control Swabs intended for use only with the ID...

Acuitas

FDA UDI

Opgen, Inc.·01812125010067·QuantStudio Real-Time PCR Instrument Qualified ...

BD MAX™ CPO

FDA UDI

BECTON, DICKINSON AND COMPANY·00382904452629·Kit BD MAX CPO

ID NOW Strep A 2

FDA UDI

Alere Scarborough, Inc.·10811877010552·A rapid, automated, molecular test for the qual...

GeneXpert®

FDA UDI

CEPHEID·07332940007690·XPERT, GENEXPERT DX SYSTEM

Alethia™ Group A Streptococcus External Control Kit

FDA UDI

MERIDIAN BIOSCIENCE, INC.·00840733102127·The Alethia™ Group A Streptococcus (Group A Str...

cobas® MRSA/SA Test

FDA UDI

Roche Molecular Systems, Inc.·00875197004410·

Revogene Strep A

FDA UDI

MERIDIAN BIOSCIENCE, INC.·00840733102325·The revogene Strep A assay, performed on the re...

GeneXpert Dx System

FDA UDI

CEPHEID·07332940003371·XPERT, GENEXPERT DX SYSTEM

Verigene® Processor SP

FDA UDI

NANOSPHERE, INC.·00857573006010·The Verigene® Processor SP is an instrument whi...