APTIMA

APTIMA - HBV VIRAL ASSAY, APTIMA, 100T, US IVD

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT). The nucleic acids detected may include genes encoding the core protein, surface antigen, e-antigen, and/or other genome regions.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MKT

Device Name: Hepatitis Viral B Dna Detection

Device Class: 3

Physical State: N/A

Definition: Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.

Submission Type ID: 2

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 15420045506749

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