Cl Electrode, Ise Module

FDA UDI

Class II (US FDA UDI)

by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Identity

Trade Name: CL ELECTRODE, ISE MODULE FDA UDI
Generic Name: Chloride (Cl-) electrode IVD FDA UDI
Device Name: Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. FDA UDI
Model / Reference: Cl- Electrode FDA UDI
Description: Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. FDA UDI

Identifiers

Catalog Number: 5203 FDA UDI
Primary DI / UDI-DI: 05999883586709 FDA UDI
510(k) Number: K101741 FDA UDI
FDA Product Code: CGZ FDA UDI
GMDN Term: Chloride (Cl-) electrode 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 60 Millimeter FDA UDI
Depth — 40 Millimeter FDA UDI
Width — 90 Millimeter FDA UDI

Category: Chloride (Cl-) electrode IVD

Cl Electrode, Ise Module by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag — Class II — FDA…

Similar devices

Also classified as Chloride (Cl-) electrode IVD.

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i-STAT — Abbott Point of Care Inc. · Class II
I.S.E. CL — Randox Laboratories, Ltd. · Class II
ISE Chloride Electrode — Medica Corp. · Class II
Chloride Electrode — Medica Corp. · Class II
Chloride Electrode — DIAMOND DIAGNOSTICS Inc
cobas b 221 Chloride Electrode — Roche Diagnostics Corp. · Class II

Cleared under the same submission

K101741 also covers:

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: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Sources (1)

FDA UDI 0da47eb8-8c23-4978-b5d5-35268ac662fb 38 fields · synced May 30, 2026