Na/K/Cl/Li Analyzer 2021

GUDID 00386100002909

EasyLyte Na/K/Cl/Li Analyzer

MEDICA CORPORATION

Ion-selective analyser IVD, automated
Primary Device ID00386100002909
NIH Device Record Key776339a7-5a22-4b6c-af9a-30be9755775c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNa/K/Cl/Li Analyzer
Version Model Number2021
Catalog Number2021
Company DUNS112942404
Company NameMEDICA CORPORATION
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100386100002909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIHFlame Photometry, Lithium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-04
Device Publish Date2018-12-04

Devices Manufactured by MEDICA CORPORATION

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00386100001742 - Chemistry HDL Calibrator Kit 2019-03-11 HDL Calibrator Kit for use with EasyRA Analyzer
00386100001766 - Chemistry LDL Calibrator2019-03-11 LDL Calibrator for use with EasyRA Analyzer
00386100001773 - Chemistry UALB Calibrator Kit2019-03-11 Microalbumin Calibrator Kit for use with EasyRA Analyzer
00386100001797 - Chemistry HbA1c Calibrator Kit2019-03-11 HbA1c Calibrator Kit for use with EasyRA Analyzer
00386100001803 - CRP Calibrator Kit2019-03-11 CRP Calibrator Kit for use with EasyRA Analyzer
00386100001858 - Wash1 Kit 2019-03-11 Wash1 Kit for use with EasyRA Analyzers
00386100001872 - QC Kit, Level A2019-03-11 EasyQC Quality Control Kit - Level for use with EasyRA Analyzer

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