Tumor Marker Control Tri-level

GUDID 00817238010134

Tumor Marker Control Tri-level

CLINIQA CORPORATION

Multiple clinical chemistry analyte IVD, control
Primary Device ID00817238010134
NIH Device Record Key52f751b1-2f78-4770-95b7-71fa08db799c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTumor Marker Control Tri-level
Version Model Number91304
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817238010134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number2
Public Version Date2019-02-04
Device Publish Date2018-08-22

On-Brand Devices [Tumor Marker Control Tri-level]

00817238010158Tumor Marker Control Tri-level
00817238010134Tumor Marker Control Tri-level

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