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Alethia Malaria

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Alethia Malaria FDA UDI
Generic Name
Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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. FDA UDI
Model / Reference
480925 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
480925 FDA UDI
Primary DI / UDI-DI
00840733102240 FDA UDI
FDA Product Code
OAX FDA UDI
GMDN Term
Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3402 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT)

Alethia Malaria by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI 05c8f084-93ba-4913-97eb-8f1715c0ba02 36 fields · synced May 30, 2026