Cardiac Marker Control 150

GUDID 00856743007017

MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).

MORE DIAGNOSTICS INC

Multiple cardiac marker IVD, control
Primary Device ID00856743007017
NIH Device Record Key6956f743-e3b8-4128-a39f-e4a79e360bc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiac Marker Control
Version Model Number150
Catalog Number150
Company DUNS829978451
Company NameMORE 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8007580978
Emailinfo@morediagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -26 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856743007017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJTEnzyme Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-30

On-Brand Devices [Cardiac Marker Control]

00856743007048MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material
00856743007031MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material
00856743007017MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material

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