130 results · 121ms · Sources: EU EUDAMED, US FDA

Alere™ BinaxNOW® Legionella Control Swab Kit

FDA UDI
Alere Scarborough, Inc.·10811877010491·Control swabs intended for use only with Legion...

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·NMP22 BLADDERCHEK TEST KIT

BinaxNOW RSV

FDA UDI
Alere Scarborough, Inc.·10811877011191·A rapid test for the qualitative detection of r...

BinaxNOW COVID-19 Antigen Self Test

FDA UDI
Alere Scarborough, Inc.·00811877011712·A rapid test for the qualitative detection of C...

Alere™ i Instrument

FDA UDI
Alere Scarborough, Inc.·00811877010838·The Alere™ i Instrument is a portable, fluoresc...

Binax® Legionella EIA Wash Buffer Accessory Kit

FDA UDI
Alere Scarborough, Inc.·10811877010767·Wash Buffer intended for use only with Binax™ L...

BinaxNOW COVID-19 Ag Positive Control Swab Pack

FDA UDI
Alere Scarborough, Inc.·10811877011306·Control swabs intended for use only with BinaxN...

BinaxNOW Streptococcus pneumoniae Antigen Card

FDA UDI
Alere Scarborough, Inc.·10811877011061·The BinaxNOW Streptococcus pneumoniae Antigen C...

WOUNDCHEK™ Bacterial Status

FDA UDI
Alere Scarborough, Inc.·10811877011245·Intended for the assessment of bacterial protea...

ID NOW™ Instrument

FDA UDI
Alere Scarborough, Inc.·00811877010616·The ID NOW™ Instrument is a portable, fluoresce...

ID NOW Strep A 2 Control Swab Kit

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

ID NOW COVID-19 2.0

FDA UDI
Alere Scarborough, Inc.·00811877011354·A rapid, automated, molecular test for the qual...

BinaxNOW RSV

FDA UDI
Alere Scarborough, Inc.·10811877011177·A rapid test for the qualitative detection of r...

Determine™ HIV–1/2 Ag/Ab Combo Controls

FDA UDI
Alere Scarborough, Inc.·00811877011125·The Determine™ HIV-1/2 Ag/Ab Combo Controls are...

DIGIVAL Calibration Check Card Pack

FDA UDI
Alere Scarborough, Inc.·10811877010798·A calibration check card verifies that the DIGI...

ID NOW Strep A 2

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

BinaxNOW RSV

FDA UDI
Alere Scarborough, Inc.·10811877011160·A rapid test for the qualitative detection of r...

ID NOW RSV Control Swab Kit

FDA UDI
Alere Scarborough, Inc.·10811877010538·Control Swabs intended for use only with the ID...

BinaxNOW® Malaria

FDA UDI
Alere Scarborough, Inc.·10811877010378·For the qualitative detection of Plasmodium fal...

BinaxNOW COVID-19 Ag Card Home Test

FDA UDI
Alere Scarborough, Inc.·00811877011330·A rapid test for the qualitative detection of C...