- Physicians Office Resource

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

Storage Environment Temperature - Degrees Celsius

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 Identifiers

Device 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

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