CARDIAC MARKER CONTROL TRI-LVL

GUDID 00817238010097

CARDIAC MARKER CONTROL TRI-LVL (min-pack)

CLINIQA CORPORATION

Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control
Primary Device ID00817238010097
NIH Device Record Keya45b815b-5d28-46dc-82d4-d8dca7db910a
Commercial Distribution Discontinuation2019-10-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCARDIAC MARKER CONTROL TRI-LVL
Version Model Number91489
Company DUNS078742335
Company NameCLINIQA CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817238010097 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-31
Device Publish Date2018-08-22

On-Brand Devices [CARDIAC MARKER CONTROL TRI-LVL]

00817238010097CARDIAC MARKER CONTROL TRI-LVL (min-pack)
00817238010080CARDIAC MARKER CONTROL TRI-LEVEL

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