Simplexa Congenital CMV Direct

Simplexa Congenital CMV Direct - MOL2255

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).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Code: OOI

Device Name: Real Time Nucleic Acid Amplification System

Device Class: 2

Physical State: Should not include microarray or electrophoresis detection methods or instruments.

Definition: The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2570

Third Party Flag: N

Medical Specialty: CH

Device Id: 20816101025835

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