Identity
- Trade Name
- Alethia™ CMV External Control Kit FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, control FDA UDI
- Device Name
- The Alethia™ CMV External Control Kit contains Positive and Negative Control Reagents for use with the Alethia CMV DNA Amplification Assay. 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
- 479880 FDA UDI
- Description
- The Alethia™ CMV External Control Kit contains Positive and Negative Control Reagents for use with the Alethia CMV DNA Amplification Assay. 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
- 479880 FDA UDI
- Primary DI / UDI-DI
- 00840733102097 FDA UDI
- FDA Product Code
- QDZ FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3181 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cytomegalovirus (CMV) nucleic acid IVD, control
Alethia™ CMV External Control Kit by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 345d2262-be42-4825-8039-27eb35af2b83 36 fields · synced May 29, 2026