BinaxNOW® Malaria

GUDID 10811877010378

For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.

Alere Scarborough, Inc.

Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical
Primary Device ID10811877010378
NIH Device Record Key5f48d5a5-fd16-4e04-aadf-7af29a3b48ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameBinaxNOW® Malaria
Version Model Number665-025
Company DUNS154148498
Company NameAlere Scarborough, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110811877010378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAXPlasmodium Spp. Detection Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2016-09-03

On-Brand Devices [BinaxNOW® Malaria]

10811877010378For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.
10811877010361For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.

Trademark Results [BinaxNOW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BINAXNOW
BINAXNOW
76505933 2861132 Live/Registered
ALERE SCARBOROUGH, INC.
2003-04-14

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