CK-MB CAL CK2393

GUDID 05055273201451

The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems.

RANDOX LABORATORIES LIMITED

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Primary Device ID05055273201451
NIH Device Record Key76b4cd3a-c7bc-43c2-a624-f8638bf22a8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCK-MB CAL
Version Model NumberCK2393
Catalog NumberCK2393
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Once reconstituted CK-MB is stable in the serum for 5 days at +4°C, 8 hours at +25°C and 4 weeks at –20°C when frozen once.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273201451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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