Alethia™ CMV 481325

GUDID 00840733102080

The Alethia CMV Assay Test System includes separately provided test kits for the Alethia CMV DNA Amplification Assay and the Alethia CMV External Control Reagents. The Alethia CMV DNA Amplification Assay, performed on the Alethia instrument, is a qualitative, in vitro diagnostic test system for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. The test is used as an aid in the diagnosis of congenital CMV infection. The results of this test should be used in conjunction with the results of other clinical findings. Flocked swabs should be used to collect saliva from neonates. The swab can be collected dry, without viral transport media (VTM), or placed in no more than 1 mL VTM. The Alethia CMV External Control Reagents 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. The external controls are intended for use with the Alethia CMV DNA Amplification Assay; the controls are not intended for use with other assays or systems.

MERIDIAN BIOSCIENCE, INC.

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00840733102080
• NIH Device Record Key: 70309339-a621-44d6-bb82-78e4d459ccb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alethia™ CMV
• Version Model Number: 481325
• Catalog Number: 481325
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 513-271-3700
• Email: info@meridianbioscience.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733102080 [Primary]

FDA Product Code

• QDZ: Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-09

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