Home/Specialty/Microbiology/Plasmodium Spp. Detection Reagents/BinaxNOW® Malaria

Alere Scarborough, Inc. 665-000 BinaxNOW® Malaria

Company Name

Alere Scarborough, Inc.

Catalog Number

665-000

Description

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

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The Alethia Malaria amplification assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic test for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection.Alethia Malaria assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assay does not distinguish between Plasmodium species.Alethia Malaria is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

MERIDIAN BIOSCIENCE, INC. 481125 Alethia Malaria PLUS

The Alethia Malaria PLUS DNA amplification assays, performed on the Alethia Incubator/Reader, are qualitative in vitro diagnostic tests for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection.Alethia Malaria assays utilize loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assays do not distinguish between Plasmodium species.Alethia Malaria PLUS is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

MERIDIAN BIOSCIENCE, INC. 479970 Alethia Malaria External Control Kit

The Alethia Malaria External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Malaria or Alethia Malaria PLUS DNA Amplification Assays. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.

MERIDIAN BIOSCIENCE, INC. 480925 Alethia Malaria

The Alethia Malaria amplification assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic test for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection.Alethia Malaria assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assay does not distinguish between Plasmodium species.Alethia Malaria is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

MERIDIAN BIOSCIENCE, INC. 481125 Alethia Malaria PLUS

The Alethia Malaria PLUS DNA amplification assays, performed on the Alethia Incubator/Reader, are qualitative in vitro diagnostic tests for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection.Alethia Malaria assays utilize loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assays do not distinguish between Plasmodium species.Alethia Malaria PLUS is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

MERIDIAN BIOSCIENCE, INC. 479970 Alethia Malaria External Control Kit

The Alethia Malaria External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Malaria or Alethia Malaria PLUS DNA Amplification Assays. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.

Additional Details

Device Identifier

10811877010361

Is RX

No

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

No

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	10811877010361