FDA.reportPublic FDA data

Nanoduct® Calibration Standard Plate

Primary DI
03661540301124
Brand
Nanoduct® Calibration Standard Plate
Company
ELITECHGROUP INC.
Model
AC-081
Device description
For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for diagnosis of Cystic Fibrosis.
Published
2021-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010031000NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMWescor, Inc.2001-03-20KTB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540301124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540301124036615403011243661540301124

GMDN Terms#

Term, Definition table
TermDefinition
Sweat-induction iontophoresis device/conductivity analyserA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-453-2725service_ebs@elitechgroup.com

Regulatory Flags#

DUNS number
052423787
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540300400Macroduct Advanced Sweat Collection SystemModel 3710-Sys2025-02-27
03661540304156Potassium Electrode279-001279-0012023-10-01
03661540304163Chloride Electrode280-001280-0012023-10-01
03661540304170Carbon Dioxide Electrode275-001275-0012023-10-01
03661540304187Sodium Electrode278-001278-0012023-10-01
03661540300288Monosed® ESR Vacuum Tubes, CartonPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonEX-50100EX-501002023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonEX-50205EX-502052023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonEP-10605EP-106052023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonEP-10605-H1EP-10605-H12023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerPRD-MSS-EL-08TKNEPRD-MSS-EL-08TKNE2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerPRD-X20-EL-08TKNEPRD-X20-EL-08TKNE2023-10-01
03661540300202Monosed® ESR Vacuum TubesPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesEX-50100EX-501002023-10-01
03661540300257Excyte® ESR Vacuum TubesEX-50205EX-502052023-10-01
03661540300264Excyte® ESR Vacuum TubeEP-10605EP-106052023-10-01
03661540300271Excyte® ESR Vacuum TubeEP-10605-H1EP-10605-H12023-10-01
03661540304286Direct A1c Control Kit55136551362023-10-01

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