Quantisal™ Oral Fluid Collection Device

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ID NOW Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

ALERE PBP2A SA/CONS CULTURE COLONY TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ALERE PBP2A TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ALERE I STREP A

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

BinaxNOW G6PD Test

FDA 510(k)

FDA Class 2 ·Hematology

WOUNDCHEK Bacterial Status

FDA 510(k)

FDA Class 2 ·Microbiology

Cholestech LDX ™ System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK

FDA 510(k)

FDA Class 2 ·Cardiovascular