FDA.reportPublic FDA data

Take-up Tubes, 14 inch, Qty 100

Primary DI
03661540302336
Brand
Take-up Tubes, 14 inch, Qty 100
Company
ELITECHGROUP INC.
Model
SS-044
Device description
The Take-up tubes are intended to be used with the 3120 SWEAT•CHEK Sweat Conductivity Analyzer for sweat analysis for the laboratory diagnosis of cystic fibrosis. The tubes allow for a sweat specimen as small as 6 to 10 microliters to be measured.
Published
2021-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGZElectrode, Ion-Specific, Chloride

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863395000WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZERWescor, Inc.1988-05-24CGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540302336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540302336036615403023363661540302336

GMDN Terms#

Term, Definition table
TermDefinition
Sweat conductivity analyser IVD, semi-automatedA portable, mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of the electrical conductivity of a sweat specimen, as an indicator of total electrolyte concentration, by measuring the ease at which an electric current passes between two points of a conductor in a flow-through cell maintained at a precisely controlled temperature. Calibration solutions and controls are used to validate these results which are typically used to help diagnose cystic fibrosis. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

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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