"MGB Alert® HHV
MGB Alert HHV-6 Probe Mix ASR - 480 rxn - 800339
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Human herpesvirus 6 (HHV6) in a clinical specimen, using a nucleic acid technique (NAT).
Environmental Conditions
- -10.00
- N/A
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MVU
Device Name: Reagents, Specific, Analyte
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
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: 864.4020
Third Party Flag: N
Medical Specialty: PA
Device IdentifiersDevice Id: 03661540951343
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