LiquidQC CoV-2 IgG Control

GUDID 00817238010035

CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays.

CLINIQA CORPORATION

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Primary Device ID00817238010035
NIH Device Record Key817fc778-bba2-4327-b5a9-201abb1f5fc6
Commercial Distribution Discontinuation2020-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLiquidQC CoV-2 IgG Control
Version Model Number91494
Company DUNS078742335
Company NameCLINIQA CORPORATION
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 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
GS100817238010035 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

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