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Alere Scarborough, Inc.

US

Last updated May 25, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
154148498

Catalogue (134)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
BinaxNOW® Malaria 665-000
FDA UDI
Class IIActive
BinaxNOW RSV 430-000
FDA UDI
Class IActive
Alere™ i Influenza A & B Control Swab Kit 425-080
FDA UDI
Class IIUnknown
ID NOW Influenza A & B 2 Control Swab Kit 425-080
FDA UDI
Class IIActive
Digival EQ00600X
FDA UDI
N/AActive
ID NOW RSV Control Swab Kit 435-080
FDA UDI
Class IIActive
BinaxNOW Strep A Card 735-025
FDA UDI
Class IActive
Binax® Legionella Urinary Antigen EIA 851-000
FDA UDI
Class IIActive
BinaxNOW RSV 430-100
FDA UDI
Class IActive
ISOLATOR™ 10 mL Microbial Tubes 50C7
FDA UDI
Class IIUnknown
BinaxNOW COVID-19 Antigen Self Test 195-261
FDA UDI
NActive
Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649
FDA UDI
Class IIUnknown
Alere™ i Influenza A & B 425-024
FDA UDI
Class IIUnknown
COVID-19 Swab Transport Accessory Pack 190-010
FDA UDI
Class IActive
BinaxNOW COVID-19 Ag Card Home Test 195-100
FDA UDI
NActive
BinaxNOW COVID-19 Antigen Self Test 195-180
FDA UDI
Class IIActive
BinaxNOW COVID-19/Flu A&B Controls 20002055
FDA UDI
Class IIActive
BinaxNOW Influenza A & B Card 2 575-000
FDA UDI
Class IIActive
Alere NMP22 BladderChek Test D1300
FDA UDI
Class IIIUnknown
Alere™ BinaxNOW® Legionella Urinary Antigen Card 852-000
FDA UDI
Class IIUnknown
BinaxNOW Streptococcus pneumoniae Control Swab Pack 710-010
FDA UDI
Class IActive
BinaxNOW COVID-19 Antigen Self Test 195-240
FDA UDI
NActive
BinaxNOW® G6PD 780-000
FDA UDI
Class IIActive
BinaxNOW COVID-19 Antigen Self Test 195-267
FDA UDI
NActive
BinaxNOW COVID-19 Ag Card Home Test 195-200
FDA UDI
NActive
BinaxNOW Strep A Control Swab Pack 730-010
FDA UDI
Class IActive
Determine™ HIV–1/2 Ag/Ab Combo Controls 7D2628
FDA UDI
Class IIActive
Alere i Influenza A & B 2 427-000
FDA UDI
Class IIUnknown
BinaxNOW COVID-19/Flu A&B 20002054
FDA UDI
Class IIActive
BinaxNOW COVID-19 Antigen Self Test 195-280
FDA UDI
NActive
BinaxNOW COVID-19/Flu A&B Combo Self Test 20002057
FDA UDI
Class IIActive
Id Now Covid-19 2.0 192-000
FDA UDI
Class IIActive
Id Now Rsv 435-000
FDA UDI
Class IIActive
BinaxNOW COVID-19 Ag Card 195-000
FDA UDI
NActive
BinaxNOW COVID-19/Flu A&B Combo Self Test 20002058
FDA UDI
Class IIActive
BinaxNOW COVID-19 Antigen Self Test 195-241
FDA UDI
NActive
BinaxNOW COVID-19/Flu A&B Combo Self Test 20002052
FDA UDI
Class IIActive
ID NOW Strep A 2 Control Swab Kit 734-080
FDA UDI
Class IIActive
Alere™ BinaxNOW® Legionella Control Swab Kit 852-010
FDA UDI
Class IIUnknown
DIGIVAL Tray Pack 1 LFR-004
FDA UDI
N/AActive
Osteomark NTx Serum 9021
FDA UDI
Class IUnknown
Alere i Strep A 2 734-000
FDA UDI
Class IIUnknown
Alere™ i Strep A Control Swab Kit 733-080
FDA UDI
Class IIUnknown
ID NOW Influenza A & B Control Swab Kit 425-080
FDA UDI
Class IIUnknown
Alere BinaxNOW Influenza A & B Card 2 575-000
FDA UDI
Class IIUnknown
WOUNDCHEK™ Bacterial Status 360006US
FDA UDI
Class IIActive
BinaxNOW COVID-19 Antigen Self Test 195-140
FDA UDI
Class IIActive
Alere NMP22 Test D1100E
FDA UDI
Class IIIActive
ISOSTAT® Containment Adapter 50C1
FDA UDI
Class IIUnknown
ID NOW COVID-19 2.0 Control Swab Kit 192-080
FDA UDI
Class IIActive

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