For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for diagnosis of Cystic Fibrosis.
Nanoduct® Calibration Standard Plate - AC-081
Device Description
A portable, battery-powered electronic device intended to induce sweating by the transdermal introduction of a water-soluble electrolytic substance (i.e., pilocarpine) into the sweat glands using an electric stimulus (iontophoresis), and subsequently measure the electrical conductivity of the sweat using a continuous flow cell; thus providing an indication of the total electrolyte concentration. It typically consists of a portable conductivity analyser that contacts the patient via microelectrodes embedded in a non-conductive sensor held against the stimulated skin. The device is used to help diagnose cystic fibrosis (CF).
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: JIS
Device Name: Calibrator, Primary
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.1150
Third Party Flag: N
Medical Specialty: CH
Device Identifiers
Device Id: 03661540301124
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
