Nanoduct® Calibration Standard Plate

GUDID 03661540301124

For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for 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 Sweat-induction iontophoresis device/conductivity analyser
Primary Device ID03661540301124
NIH Device Record Key63f64175-8aed-4948-94f5-ba81fd87d5a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoduct® Calibration Standard Plate
Version Model NumberAC-081
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 Numberfalse
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

Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540301124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JISCalibrator, Primary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-01
Device Publish Date2021-02-19

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Trademark Results [Nanoduct]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NANODUCT
NANODUCT
76262460 2633198 Live/Registered
ELITECHGROUP INC.
2001-05-25

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