EV/TAC/CsA Control 305-1

GUDID 00856743007284

MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of everolimus, tacrolimus, and cyclosporine.

MORE DIAGNOSTICS INC

Multiple immunosuppressant therapeutic drug monitoring IVD, control
Primary Device ID00856743007284
NIH Device Record Keyc43dc728-fa8c-4b65-8cb8-58de336643fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameEV/TAC/CsA Control
Version Model Number305-1
Catalog Number305-1
Company DUNS829978451
Company NameMORE DIAGNOSTICS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone800-758-0978
Emailinfo@morediagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -14 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856743007284 [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 Date2019-08-14
Device Publish Date2019-08-06

On-Brand Devices [EV/TAC/CsA Control]

00856743007307MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control pr
00856743007291MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control pr
00856743007284MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control pr
00856743007277MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control pr

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