LIQUID CARDIAC CONTROL 1 CQ10534

GUDID 05055273219043

The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.

RANDOX LABORATORIES LIMITED

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device ID05055273219043
NIH Device Record Keybb7af79d-c4a4-449c-8b5e-de2c782043e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIQUID CARDIAC CONTROL 1
Version Model NumberCQ10534
Catalog NumberCQ10534
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273219043 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-31
Device Publish Date2025-03-21

Devices Manufactured by RANDOX LABORATORIES LIMITED

05055273210101 - Liquid Immunoassay Control – Level 1 (IA CONTROL 1)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
05055273210118 - LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
05055273210125 - LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
05055273219814 - PTH CONTROL LEVEL 1 (PTH CONTROL 1)2025-04-01 The PTH Control Level 1 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
05055273219821 - PTH CONTROL LEVEL 2 (PTH CONTROL 2)2025-04-01 The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
05055273219838 - PTH CONTROL LEVEL 3 (PTH CONTROL 3)2025-04-01 The PTH Control Level 3 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
05055273219043 - LIQUID CARDIAC CONTROL 12025-03-31The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, High Sensitivity C-Reactive Protein (hsCRP), Digoxin, Homocysteine, Myoglobin, NT-proBNP and Troponin I. Liquid Cardiac Controls are assayed with target values and are suitable for use on automated chemistry and immunoassay analysers. Liquid Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
05055273219043 - LIQUID CARDIAC CONTROL 12025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig
05055273219050 - LIQUID CARDIAC CONTROL 22025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig

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