FDA.reportPublic FDA data

FREND Free T4

Primary DI
08809317540382
Brand
FREND Free T4
Company
NanoEnTek, Inc.
Model
FRT4-AP
Catalog number
FRT4AP 020
Device description
It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.
Published
2018-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CECRadioimmunoassay, Free Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CECRadioimmunoassay, Free ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152422000FREND™ Free T4 Test SystemNanoentek USA, Inc.2016-02-17CEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809317540382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317540382088093175403828809317540382

GMDN Terms#

Term, Definition table
TermDefinition
Free thyroxine (FT4) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of free thyroxine (FT4) 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
08809317540917COVID-19 total Ab Control LQFIC-COALQFIC-COALQ2020-09-02
08809317540924FREND COVID-19 total AbFREND COVID-19 total AbFRCOA 0202020-09-02
08809317540825FREND Blocking ReagentFRBR 015FRBR 0152020-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590780982Access Free T4Beckman Coulter, Inc.CEC2024-03-12
00850049545990QMedix™Diagnostic Automation, Inc.CEC2024-02-02
04048474042665Free Thyroxine (fT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEC2023-08-31
00894175000923AccuDiag ™Diagnostic Automation, Inc.CEC2023-06-14
07613336175071Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-03
07613336172780Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-02
06947145577971MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
06947145577988MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
00630414293851Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414294292Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414599144Atellica IM FT4 MCMSiemens Healthcare Diagnostics Inc.CEC2020-09-24
00630414293684Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00630414294193Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00840239042668Free Thyroxine (fT4) ELISADRG International IncCEC2019-06-10
00816870021713Free T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870021720Free T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870021737Monobind AccuBind Free T4 ELISA Kit - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870021744Free T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CEC2019-02-11
00816870023151Free T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870023168Free T4 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870023175Free T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870023182Monobind AccuLite Free T4 CLIA Kit - 960 WellsMONOBIND, INC.CEC2019-02-11
00380740121822AlinityABBOTT IRELANDCEC2018-07-31
00380740121815AlinityABBOTT IRELANDCEC2018-05-31
00380740119799ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119805ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119812ARCHITECTABBOTT IRELANDCEC2018-05-14
00630414599120Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06
00630414599137Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06
00630414599977Atellica IM T4Siemens Healthcare Diagnostics Inc.CEC2018-02-06