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.
Alethia™ CMV External Control Kit - 479880
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen.
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: 00840733102097
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