SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

GUDID 00811403010028

The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer is a 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. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack every 4 hours throughout the day or on request. 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.

Diamond Diagnostics Inc.

Ion-selective analyser IVD
Primary Device ID00811403010028
NIH Device Record Key59e64393-97ea-4ed0-b9ac-deb21aeec548
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Version Model Number0-DD-SMARTLYTEPLUS
Company DUNS947514303
Company NameDiamond Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811403010028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-13
Device Publish Date2023-06-05

Devices Manufactured by Diamond Diagnostics Inc.

00811403010158 - Photometer Lamp2023-06-21
00811403010240 - Reference Solution2023-06-21
00811403013074 - Pump Tubing Kit2023-06-21
00811403013173 - C1/C2 Cleaning Solution2023-06-21
00811403010387 - Wash Pack2023-06-21
00811403013296 - pH Electrode2023-06-21
00811403013302 - Calcium Electrode2023-06-21
00811403013319 - Potassium Electrode2023-06-21

Trademark Results [SmartLyte]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMARTLYTE
SMARTLYTE
76698012 3848109 Live/Registered
Diamond Diagnostics Inc.
2009-06-22
SMARTLYTE
SMARTLYTE
76504618 3140826 Dead/Cancelled
Acolyte Technologies Corporation
2003-04-08
SMARTLYTE
SMARTLYTE
76063793 not registered Dead/Abandoned
Acolyte Systems Inc.
2000-06-02
SMARTLYTE
SMARTLYTE
76063792 not registered Dead/Abandoned
Acolyte Systems Inc.
2000-06-02
SMARTLYTE
SMARTLYTE
74663526 not registered Dead/Abandoned
IQ International, Inc.
1995-04-20

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