Identity
- Trade Name
- Alethia Malaria PLUS FDA UDI
- Generic Name
- Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 481125 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 481125 FDA UDI
- Primary DI / UDI-DI
- 00840733102257 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
- Not 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
Alethia Malaria PLUS by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI e3fd9dd3-a209-4515-9c4f-8477ec08b2fc 37 fields · synced May 31, 2026