1,242 results · 79ms · Sources: EU EUDAMED, US FDA

Salicylates Direct ELISA Kit

FDA registration
Alere San Diego Inc.·1 product·🇺🇸 United States

Immunalysis Ethyl Glucuronide Controls

FDA registration
Alere San Diego Inc.·1 product·🇺🇸 United States

Sure-Vue Serum/Urine hCG

FDA registration
ABON BIOPHARM (HANGZHOU) CO., LTD.·1 product·🇨🇳 China

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

FDA Pre-Market Approval
FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AFP RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AFP RIA KIT

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

FDA Pre-Market Approval
FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

Tanner Scientific Inc. BluRapids Multi-Drug Urine Test Panel

FDA registration
GUANGZHOU WONDFO BIOTECH CO., LTD.·1 product·🇨🇳 China

Tanner Scientific Inc. BluRapids Multi-Drug Urine Test Panel

FDA registration
GUANGZHOU WONDFO BIOTECH CO., LTD.·1 product·🇨🇳 China

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...