FDA.reportPublic FDA data

Fluoro-CheckTM Influenza A+B

Primary DI
00895160002526
Brand
Fluoro-CheckTM Influenza A+B
Company
NANO-DITECH CORPORATION
Model
TF8147
Catalog number
TF8147
Device description
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
Published
2019-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSZDevices Detecting Influenza A, B, And C Virus Antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002526PrimaryGS10
10895160002523Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002526008951600025268951600025260895160002526
1089516000252310895160002523

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-297-7877info@nanoditech.com
1-609-406-3300info@nanoditech.com

Regulatory Flags#

DUNS number
126544316
Device count
20
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00895160002427Fluoro-CheckTM PCTTF3161TF31612016-10-05
00895160002878Nano-Check™ Influenza A+B TestMD81532026-01-22
10895160002875Nano-Check™ Influenza A+B TestMD81532026-01-22
00895160002960Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
00895160002847Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
00895160002854Nano-Check RSV TestMD81522024-08-08
00895160002861Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
10895160002868Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
00895160002786Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147-20T2020-11-18
00895160002243Nano-Check™ OPI TestAD41832023-06-27
10895160002240Nano-Check™ OPI TestAD41832023-06-27
00895160002663Nano-CheckTM COVID-19 IgG/IgM Antibody TestMD81452020-04-10
00895160002670Fluoro-CheckTM CRP Test TF31632020-09-22
00895160002687Nano-Check TM Strep A TestMD81482022-03-15
00895160002694Nano-Check TM CRP plus TestCD71572022-03-15
00895160002724Nano-Check TM COVID-19 IgG Antibody TestMD81462020-09-22
00895160002793Fluoro-Check TM COVID-19 Antigen TestTF-81502020-11-25
00895160002120Nano-CheckTM AMI 2 in 1CD202PCD202P2016-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06970640093097INNOVITAInnovita (Tangshan) Biological Technology Co., Ltd.PSZ2026-04-15
00742860100413Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
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00742860100475Acucy System Universal DrawerSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONPSZ2024-08-08
20885380200844CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
50885380200845CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
00850056728706ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen TestLumos Diagnostics, Inc.PSZ2023-11-30
00848838027031Remel REMEL, INC.PSZ2021-11-12
30848838027032Remel REMEL, INC.PSZ2021-11-12
03848838027038Remel REMEL, INC.PSZ2021-11-12
10743816001553Status™ COVID-19/FluPRINCETON BIOMEDITECH CORPORATIONPSZ2021-02-15
00742860100390OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control KitSEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
10742860100397OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100338Acucy SystemSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24
00742860100345Acucy Calibration DeviceSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24
00742860100383Acucy Influenza A&B Control KitSEKISUI DIAGNOSTICS, LLCPSZ2019-08-23
00742860100376Acucy Flu Test KitSEKISUI DIAGNOSTICS, LLCPSZ2019-08-20
10811877010972BinaxNOW Influenza A & B Card 2Alere Scarborough, Inc.PSZ2019-07-15
10811877010989BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.PSZ2019-07-15
10811877010422ID NOW Influenza A & B 2Alere Scarborough, Inc.PSZ2018-10-29
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.PSZ2018-10-29
10854916006796MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
10854916006802MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
00382902560715BD Veritor™ System CLIA-Waived Combo PackBECTON, DICKINSON AND COMPANYPSZ2018-05-25
00840733101649ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate KitMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12
00840733101656ImmunoCard STAT! FLU A&BMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12