FDA.reportPublic FDA data

Nano-Check RSV Test

Primary DI
00895160002854
Brand
Nano-Check RSV Test
Company
NANO-DITECH CORPORATION
Model
MD8152
Device description
The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age.
Published
2024-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial VirusMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002854PrimaryGS10
10895160002851Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002854008951600028548951600028540895160002854
1089516000285110895160002851

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
609-409-3300info@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
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
00895160002359Nano-CheckTM NicotineAD6083AD60832016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950921308096CLUNGENEHangzhou Clongene Biotech Co., Ltd.GQG2026-04-11
00742860100666OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
10742860100663OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
20612479277278McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
40612479277289McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
00810160810377Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00810160810360Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00612479269880McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2024-09-09
00612479269897McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2024-09-09
05032384502950IMAGEN Respiratory Syncytial Virus (RSV)OXOID LIMITEDGQG2024-06-19
10722066008031Rapid ResponseBTNX IncGQG2024-02-21
00722066008034Rapid ResponseBTNX IncGQG2024-02-21
08033891327668CHORUS RESPIRATORY SYNCYTIAL VIRUS IgGDIESSE DIAGNOSTICA SENESE SPAGQG2024-01-22
10694644700036Easy Lab Pro RSVAMERICAN BIO MEDICA CORPORATIONGQG2023-01-12
00840733101847TRU RSVMERIDIAN BIOSCIENCE, INC.GQG2020-12-09
00840733101977FLU/RSV Positive ControlMERIDIAN BIOSCIENCE, INC.GQG2020-11-17
10811877010484BinaxNOW Nasopharyngeal Swab Accessory KitAlere Scarborough, Inc.GQG2020-09-16
10811877011160BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011177BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011184BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011191BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011207BinaxNOW RSV Control Swab KitAlere Scarborough, Inc.GQG2020-09-16
30014613201939QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202226QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202424SofiaQUIDEL CORPORATIONGQG2018-11-10
30014613202608SofiaQUIDEL CORPORATIONGQG2018-11-10
00382902560388BD Veritor™ System For Rapid Detection of RSV - CLIA waived kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
00382902560425BD Veritor™ System For Rapid Detection of RSV - Laboratory kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
10627966005183RAMP® RSV TEST KIT; 25 TESTSResponse Biomedical CorpGQG2017-08-31
10627966005206RAMP® RSV Control SwabsResponse Biomedical CorpGQG2017-08-31