FDA.reportPublic FDA data

COVID-19 total Ab Control LQ

Primary DI
08809317540917
Brand
COVID-19 total Ab Control LQ
Company
NanoEnTek, Inc.
Model
FIC-COALQ
Catalog number
FIC-COALQ
Device description
The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard.
Published
2020-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QKOReagent, Coronavirus Serological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKOReagent, Coronavirus SerologicalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809317540917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317540917088093175409178809317540917

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 total antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687910463
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809317540252ADAM-rWBCADAM-rWBC ADAM-rWBC2018-06-11
08809317540269ADAM-rWBC KitAD1K-050AD1K-0502016-09-30
08809317540276ADAM-rWBC SystemADAM-rWBC SystemADAM-rWBC System2016-09-30
08809317540498ADAM-rWBC2ADAM-rWBC2ADAM-rWBC22018-06-19
08809317540504ADAM-rWBC2 SystemADAM-rWBC2 SystemADAM-rWBC2 System2018-06-19
08809317540207FREND SystemF102018-05-04
08809317540153FREND TestosteroneFRTE-HBFRTE 0202016-11-28
08809317540375FREND TestosteroneFRTE-APFRTEAP 0202018-05-04
08809317540467FREND APF10AP2018-06-11
08809317541143r-Control RBC and PLTADRCADRC 0202021-12-08
08809317540993ADAM-rWBC HTADAM-rWBC HTADAM-rWBC HT2021-02-15
08809317541006ADAM-rWBC KitADHK-050ADHK-0502021-02-15
08809317540528FREND Free T4 Linearity KitFLK-FT42018-10-01
08809317540559FREND TSH Linearity KitFLK-TSH2018-10-01
08809317540566FREND Vitamin D Linearity KitFLK-VTD2018-10-01
08809317540627ADAMIIADAMII2020-09-02
08809317540634ADAMII-CD34 KitCD34K-050CD34K-0502020-09-02
08809317540924FREND COVID-19 total AbFREND COVID-19 total AbFRCOA 0202020-09-02
08809317540825FREND Blocking ReagentFRBR 015FRBR 0152020-03-24
08809317540016FREND TSHFRTS 025FRTS 0252016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816870023601SARS-CoV-2 IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870023632SARS-CoV-2 IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023649SARS-CoV-2 IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870024868SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870024875SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
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B379COVEM1SCoV-2 Detect™ IgM ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVGRE1SCoV-2 Detect™ IgG Rapid TestINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVNE1SCoV-2 Detect™ Neutralizing Ab ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
06973774259803Biohit SARS-CoV-2 IgM/IgG Antibody Test KitBiohit Healthcare (Hefei) Co., Ltd.QKO2022-08-16
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15099590738617Access SARS-CoV-2 IgMBeckman Coulter, Inc.QKO2022-05-04
15099590738624Access SARS-CoV-2 IgM CalibratorBeckman Coulter, Inc.QKO2022-05-04
15099590738631Access SARS-CoV-2 IgM QCBeckman Coulter, Inc.QKO2022-05-04
15099590738648Access SARS-CoV-2 IgGBeckman Coulter, Inc.QKO2022-05-04
15099590738655Access SARS-CoV-2 IgG CalibratorBeckman Coulter, Inc.QKO2022-05-04
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15099590742744Access SARS-CoV-2 IgG IIBeckman Coulter, Inc.QKO2022-05-04
15099590742751Access SARS-CoV-2 IgG II CalibratorBeckman Coulter, Inc.QKO2022-05-04
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