Cardiac Control Marker 150-1

GUDID 00856743007024

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 ID00856743007024
NIH Device Record Key11ad351f-caeb-47ff-89ec-1dfe1804ddd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiac Control Marker
Version Model Number150-1
Catalog Number150-1
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

Phone18007580978
Emailinfo@morediagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -26 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856743007024 [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 Date2018-03-31

Devices Manufactured by MORE DIAGNOSTICS INC

00856743007277 - EV/TAC/CsA Control2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
00856743007284 - EV/TAC/CsA Control2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
00856743007291 - EV/TAC/CsA Control2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
00856743007307 - EV/TAC/CsA Control2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
00856743007017 - Cardiac Marker Control2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro
00856743007024 - Cardiac Control Marker2018-07-06MORE 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).
00856743007024 - Cardiac Control Marker2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro
00856743007031 - Cardiac Marker Control2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro
00856743007048 - Cardiac Marker Control2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro
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