Take-up Tubes, 14 inch, Qty 100

FDA UDI

Class II (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name: Take-up Tubes, 14 inch, Qty 100 FDA UDI
Generic Name: Sweat conductivity analyser IVD FDA UDI
Device Name: 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. FDA UDI
Model / Reference: SS-044 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 03661540302336 FDA UDI
510(k) Number: K863395 FDA UDI
FDA Product Code: CGZ FDA UDI
GMDN Term: Sweat conductivity analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1170 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Sweat conductivity analyser IVD

Take-up Tubes, 14 inch, Qty 100 by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sweat conductivity analyser IVD.

Sweat-Chek™ Sweat Conductivity Analyzer — ELITECHGROUP INC. · Class II

Cleared under the same submission

K863395 also covers:

Sweat-Chek™ Sweat Conductivity Analyzer — ELITECHGROUP INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Elitechgroup Inc.

Sources (1)

FDA UDI 5a7988d6-a9a7-4a85-92e1-bdbc1003dfb8 35 fields · synced May 31, 2026