MagMAX™ Viral/Pathogen Proteinase K - A42363LT
Device Description
A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PFT
Device Name: Reagents For Molecular Diagnostic Test Systems
Device Class: 1
Physical State: Individual reagents or reagent packages
Definition: A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.
Submission Type ID: 4
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Not applicable
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Not applicable
Regulation Number: 862.3800
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 10190302015790
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