FDA.reportPublic FDA data

Nano-CheckTM 4 in 1 Test

Primary DI
00895160002458
Brand
Nano-CheckTM 4 in 1 Test
Company
NANO-DITECH CORPORATION
Model
CD402P
Catalog number
CD402P
Device description
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma
Published
2016-10-03
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
DDRMyoglobin, Antigen, Antiserum, Control
JHTChromatographic Separation, Cpk Isoenzymes
MMIImmunoassay Method, Troponin Subunit
NBCTest, Natriuretic Peptide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2
JHTChromatographic Separation, Cpk IsoenzymesClinical Chemistry2
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2
NBCTest, Natriuretic PeptideClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002458PrimaryGS10
10895160002455Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002458008951600024588951600024580895160002458
1089516000245510895160002455

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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 B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) 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
Storage 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590786533Access BNP IIBeckman Coulter, Inc.NBC2026-03-30
10758750033522VITROSORTHO CLINICAL DIAGNOSTICSMMI2025-12-30
10054749003058i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
00054749003051i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)AXIS-SHIELD DIAGNOSTICS LIMITEDNBC2025-02-26
04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
15099590760823Access NT-proBNPBeckman Coulter, Inc.NBC2024-04-19
07613336217689Elecsys ProBNP IIRoche Diagnostics GmbHNBC2024-02-19
00630414284927ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284934ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284941Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284958Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00380740194062AlinityABBOTT IRELANDMMI2022-07-08
00380740194079AlinityABBOTT IRELANDMMI2022-07-08
07613336191521Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191569Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191576Elecsys proBNP II STAT ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336158951Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2022-03-01
10758750033300VITROSORTHO CLINICAL DIAGNOSTICSNBC2021-11-08
07613336158982Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2021-09-23
00894175000466RapiCard™ InstaTestDiagnostic Automation, Inc.MMI2021-08-27
15099590750947Access BNP Beckman Coulter, Inc.NBC2021-08-18
14560189212876ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
04560189212879ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
07613336147863Tina-quant Myoglobin Gen.2Roche Diagnostics GmbHDDR2020-08-21
00083059070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.MMI2020-07-01
00630414293462Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00630414294032Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00630414293783Atellica IM TNIHSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00630414293790Atellica IM TnI-UltraSiemens Healthcare Diagnostics Inc.MMI2020-05-31