ABBOTT TEST PACK STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

QUIKPAC STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

DIRECTIGEN 1-2-3 GROUP A STREP TEST

FDA 510(k)

FDA Class 1 ·Microbiology

BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI

FDA 510(k)

FDA Class 1 ·Microbiology

LEECO VIS-CUBE STREP A (EIA)

FDA 510(k)

FDA Class 1 ·Microbiology

BINAX STREP A

FDA 510(k)

FDA Class 1 ·Microbiology

SEROIDEN STREPTO KIT 'EIKEN'

FDA 510(k)

FDA Class 1 ·Microbiology

REVEAL COLOUR STREP A ZL16

FDA 510(k)

FDA Class 1 ·Microbiology

DIFCO STREP A LATEX TEST

FDA 510(k)

FDA Class 1 ·Microbiology

NOVA STREP A

FDA 510(k)

FDA Class 1 ·Microbiology

SERO-STAT STREPTOCOCCUS TEST

FDA 510(k)

FDA Class 1 ·Microbiology

STREP-TEX

FDA 510(k)

FDA Class 1 ·Microbiology

STREPTO-SEC TM

FDA 510(k)

FDA Class 1 ·Microbiology

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST

FDA 510(k)

FDA Class 1 ·Microbiology

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System

FDA 510(k)

FDA Class 2 ·Microbiology

NxTAG® Respiratory Pathogen Panel

FDA 510(k)

FDA Class 2 ·Microbiology

TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)

FDA 510(k)

FDA Class 2 ·Microbiology

SIMPLEXA FLU A/B & RSV

FDA 510(k)

FDA Class 2 ·Microbiology