HIV RNA 3.0 Assay (bDNA) US IVD (Box 2)

HIV RNA 3.0 Assay (bDNA) US IVD (Box 2)
VERSANT® HIV-1 RNA 3.0 Assay bDNA - 10335367

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MZF

Device Name: Test, Hiv Detection

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.3956

Third Party Flag: N

Medical Specialty: MI

Device Id: 00630414457611

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