Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genotype II Assay

Uracil
RealTime - 08L21-66

A substance or reactant intended to be used as a hydrolyzing enzyme in a molecular assay to prevent contamination of the resulting deoxyribonucleic acid (DNA) amplicon, by preventing unintentional carry over of amplification products from a previous assay, in the analysis of a clinical laboratory specimen, using a polymerase chain reaction (PCR) technique.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OBF

Device Name: Assay, Genotyping, Hepatitis C Virus

Device Class: 2

Physical State: RT-PCR amplification

Definition: In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human specimens

Regulation Number: 866.3170

Third Party Flag: N

Medical Specialty: MI

Device Id: 00884999036444

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