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Abbott Diagnostics Scarborough, Inc.

Active US-MF-000014444 36 devices in the public register. · United States
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Devices

DeviceStatusRisk
ID NOW™ Instrument (OUS)
00811877010593
On the marketClass A
DIGIVAL Tray 1 Pack
10811877011214
On the marketClass A
DIGIVAL™ Calibration Check Card Pack
10811877010798
On the marketClass A
DIGIVAL™
00811877010623
On the marketClass A
Binax™ Legionella EIA Wash Buffer Accessory Kit (4 WASHCONC)
10811877010767
On the marketIVD general
BinaxNOW™ Malaria
10811877010033
On the marketIVD general
BinaxNOW™ Malaria Positive Control Kit (10)
10811877010712
On the marketIVD general
BinaxNOW™ Strep A Card (25T)
10811877010927
On the marketIVD general
BinaxNOW™ Streptococcus pneumoniae Antigen Card (22T)
10811877011085
On the marketIVD general
BinaxNOW™ RSV Card (42T)
10811877011160
On the marketIVD general
BinaxNOW™ Influenza A & B Card 2 Control Swab Kit (10 POS+10 NEG)
10811877010989
Not intended for the EU marketIVD general
BinaxNOW™ Malaria (25T)
10811877010354
On the marketIVD general
BinaxNOW™ Legionella Urinary Antigen Card (22T)
10811877011047
On the marketIVD general
BinaxNOW™ RSV Card (22T)
10811877011177
On the marketIVD general
BinaxNOW™ RSV Control Swab Kit (10 POS+10 NEG)
10811877011207
On the marketIVD general
BinaxNOW™ Strep A Control Swab Kit (5 POS+5 NEG)
10811877010446
On the marketIVD general
BinaxNOW™ Streptococcus pneumoniae Control Swab Pack (5 POS+5 NEG)
10811877011092
On the marketIVD general
BinaxNOW™ Streptococcus pneumoniae Antigen Card (12T)
10811877011078
On the marketIVD general
Bioline Filariasis Test Strip (30T)
00811877011286
On the marketIVD general
Clearview™ PBP2a SA Culture Colony Test (25T)
10811877011238
On the marketIVD general
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Each device above has its own page. The table is one page of the public register, not every device this actor has ever registered. Not an official European Commission page.