CK-MB CK4043

GUDID 05055273213973

The device is intended for the quantitative in vitro determination of CK-MB concentration in serum or plasma.

RANDOX LABORATORIES LIMITED

Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
Primary Device ID05055273213973
NIH Device Record Keyb4afdf66-da30-4558-bde0-9517f9ed4948
Commercial Distribution StatusIn Commercial Distribution
Brand NameCK-MB
Version Model NumberCK4043
Catalog NumberCK4043
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 opened, the reagent is stable on board the analyzer for 28 days at +10°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273213973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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

On-Brand Devices [CK-MB]

05055273213973The device is intended for the quantitative in vitro determination of CK-MB concentration in ser
05055273201444The device is intended for the quantitative in vitro determination of CK-MB concentration in ser
05055273201420The device is intended for the quantitative in vitro determination of CK-MB concentration in ser

Trademark Results [CK-MB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CK-MB
CK-MB
73193560 not registered Dead/Abandoned
AMERICAN HOSPITAL SUPPLY CORPORATION
1981-08-25

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