Identity
- Trade Name
- Alethia Malaria External Control Kit FDA UDI
- Generic Name
- Multiple Plasmodium species nucleic acid IVD, control FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 479970 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 479970 FDA UDI
- Primary DI / UDI-DI
- 00840733102165 FDA UDI
- FDA Product Code
- OAX FDA UDI
- GMDN Term
- Multiple Plasmodium species nucleic acid IVD, control 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, control
Alethia Malaria External Control Kit 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 8e221807-1573-48b4-a5a6-5f393327a70d 36 fields · synced May 29, 2026