1,242 results
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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...