DEVICE: SmartLyte Electrolyte Analyzer (00811403019892)
Device Identifier (DI) Information
SmartLyte Electrolyte Analyzer
0-DD-SMARTLYTE
Not in Commercial Distribution
Diamond Diagnostics Inc.
0-DD-SMARTLYTE
Not in Commercial Distribution
Diamond Diagnostics Inc.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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56682 | Ion-selective analyser IVD |
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.
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FDA Product Code
[?]Product Code | Product Code Name |
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CEM | Electrode, Ion Specific, Potassium |
CGZ | Electrode, Ion-Specific, Chloride |
JFP | Electrode, Ion Specific, Calcium |
JGS | Electrode, Ion Specific, Sodium |
JIH | Flame Photometry, Lithium |
JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
319f766d-3d2e-4495-af46-19edbbb34dac
June 13, 2023
1
June 05, 2023
June 13, 2023
1
June 05, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined