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.
Alethia™ CMV - 481325
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen, using a nucleic acid technique (NAT).
Environmental Conditions
- 30.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QDZ
Device Name: Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Device Class: 2
Physical State: In vitro diagnostic device
Definition: The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Qualitative DNA amplification technology
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Human clinical specimens
Regulation Number: 866.3181
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840733102080
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A