SmartLyte Electrolyte Analyzer

FDA UDI

Class II (US FDA UDI)

by DIAMOND DIAGNOSTICS Inc

Identity

Trade Name: SmartLyte Electrolyte Analyzer FDA UDI
Generic Name: Ion-selective analyser IVD FDA UDI
Device Name: SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. It is microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. FDA UDI
Model / Reference: 0-DD-SMARTLYTE FDA UDI
Description: SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. It is microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. FDA UDI

Identifiers

Primary DI / UDI-DI: 00811403019892 FDA UDI
FDA Product Code: CEM FDA UDI
CGZ FDA UDI
JFP FDA UDI
JGS FDA UDI
JIH FDA UDI
JJE FDA UDI
GMDN Term: Ion-selective analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1600 FDA UDI
862.1170 FDA UDI
862.1145 FDA UDI
862.1665 FDA UDI
862.3560 FDA UDI
862.2160 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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SmartLyte Electrolyte Analyzer by DIAMOND DIAGNOSTICS Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: DIAMOND DIAGNOSTICS Inc

Sources (1)

FDA UDI 319f766d-3d2e-4495-af46-19edbbb34dac 34 fields · synced May 30, 2026