Cervista HTA System


Product Overview

Cervista HTA System - Cervista HTA System Computer


Device Description

A mains electricity (AC-powered) laboratory instrument intended to be used for the pre-analytical preparation of samples for downstream nucleic acid amplification/analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion, nucleic acid purification, and/or nucleic acid thermal incubation. The device operates with minimal technician involvement and automation of some but not all procedural steps.


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: MAQ

Device Name: Kit, Dna Detection, Human Papillomavirus

Device Class: 3

Physical State: N/A

Definition: N/A

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 Identifiers

Device Id: 15420045501065

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


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