FDA.reportPublic FDA data

FREND PSA Plus

Primary DI
08809317540184
Brand
FREND PSA Plus
Company
NanoEnTek, Inc.
Model
FRPS 025
Catalog number
FRPS 025
Device description
It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.
Published
2016-09-30
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
LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTJProstate-Specific Antigen (Psa) For Management Of Prostate CancersImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124056000FREND PSA PLUS (REAGENT CARTRIDGE)Nanoentek, Inc.2013-05-29LTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809317540184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317540184088093175401848809317540184

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen, using a fluorescent immunoassay method.

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
07613336217672Elecsys free PSARoche Diagnostics GmbHLTJ2024-10-24
00630414293738Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2020-05-31
00630414294230Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2020-05-31
00816870020594Free fPSA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020600Free fPSA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870020617Total PSA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020624Total PSA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870020631Total PSA Extra Sensitive AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020648Total PSA Extra Sensitive AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022277Free PSA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022284Monobind AccuLite Free PSA CLIA Kit - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022291Total PSA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022307Total PSA AccuLite CLIA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022314Total PSA Extra Sensitive AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022321Total PSA Extra Sensitive AccuLite CLIA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00630414599809Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2018-11-14
00630414599816Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2018-11-14
00630414599823Atellica IM PSA MCMSiemens Healthcare Diagnostics Inc.LTJ2018-11-14
08809317540481FREND PSA PlusNanoEnTek, Inc.LTJ2018-05-04
30816467020014FastPack® IP Total PSA Kit (90)QUALIGEN INC.LTJ2017-09-14
10816467020010FastPack® Total PSA Kit (50)QUALIGEN INC.LTJ2016-09-16
20816467020017FastPack® IP Total PSA Kit (30)QUALIGEN INC.LTJ2016-09-16
10758750000319VITROSORTHO CLINICAL DIAGNOSTICSLTJ2016-08-26
10758750001309VITROSORTHO CLINICAL DIAGNOSTICSLTJ2016-08-26
00380740008963ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008970ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008987ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008994ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
14560189212104ST AIA-PACK PATOSOH CORPORATIONLTJ2014-09-24
00630414202952ADVIA Centaur® Systems, ACS 180® Systems PSA MCMSiemens Healthcare Diagnostics Inc.LTJ2014-09-24