Nanoduct Neonatal Sweat Analysis System

GUDID 03661540303418

The Nanoduct Neonatal Sweat Analysis System is intended for laboratory use by qualified personnel to provide laboratory confirmation of a clinical diagnosis of cystic fibrosis.

ELITECHGROUP INC.

Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser Sweat-induction iontophoresis device/conductivity analyser
Primary Device ID03661540303418
NIH Device Record Key853c9eea-c9fc-48ed-bdd8-5b000ffb5fd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoduct Neonatal Sweat Analysis System
Version Model NumberNanoduct Sys 1030
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]
GS103661540303418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses
KTBDevice, Iontophoresis, Specific Uses

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-22
Device Publish Date2016-09-24

Devices Manufactured by ELITECHGROUP INC.

03661540302022 - Nanoduct® Electrode Cable Set Assembly2021-03-02 For use with Nanoduct Neonatal Sweat Analysis System to induce sweat for diagnosis of Cystic Fibrosis.
03661540300011 - 12-slide vented carousel for Aerospray®2021-03-01 A 12-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.
03661540300028 - 30-slide vented carousel for Aerospray®2021-03-01 A 30-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.
03661540300196 - OSMOCOLL® HNL osmolality Controls, 6x1mL2021-03-01 Osmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a vapor pressure osmometer.
03661540301124 - Nanoduct® Calibration Standard Plate2021-03-01 For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for diagnosis of Cystic
03661540301179 - Cytopro® Rotor2021-03-01 The Cytopro Cytocentrifuge rotor is an in vitro diagnostic medical device for fixing biological cell suspensions on glass micros
03661540301483 - OPTIMOLE™ Osmolality Standard, 100 mmol/kg, 60x.4mL2021-03-01 ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.
03661540301490 - OPTIMOLE™ Osmolality Standard, 290 mmol/kg, 60x.4mL2021-03-01 ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.

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