FDA.reportPublic FDA data

Nano-CheckTM AMI 2 in 1

Primary DI
00895160002083
Brand
Nano-CheckTM AMI 2 in 1
Company
NANO-DITECH CORPORATION
Model
CD201S
Catalog number
CD201S
Device description
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human serum and plasma
Published
2016-09-14
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
MMIImmunoassay Method, Troponin Subunit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102441000NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBINNano-Ditech Corporation2010-10-20MMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002083PrimaryGS10
10895160002080Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002083008951600020838951600020830895160002083
1089516000208010895160002080

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cardiac marker 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 qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. These cardiac markers may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.

Storage And Handling#

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

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

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Primary DI, Brand, Company table
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04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
00380740194062AlinityABBOTT IRELANDMMI2022-07-08
00380740194079AlinityABBOTT IRELANDMMI2022-07-08
07613336158951Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2022-03-01
07613336158982Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2021-09-23
00894175000466RapiCard™ InstaTestDiagnostic Automation, Inc.MMI2021-08-27
07613336147863Tina-quant Myoglobin Gen.2Roche Diagnostics GmbHDDR2020-08-21
00083059070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.MMI2020-07-01
00630414293783Atellica IM TNIHSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00630414293790Atellica IM TnI-UltraSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00630414285047N Latex MyoglobinSiemens Healthcare Diagnostics Products GmbHDDR2020-05-29
00380740175498ARCHITECTABBOTT IRELANDMMI2019-12-03
00380740175504ARCHITECTABBOTT IRELANDMMI2019-12-03
00842768037726Dimension EXL LOCI Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-10-16
00380740174910AlinityAbbott Ireland DiagnosticsDDR2019-10-09
00842768037719Dimension Vista Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-08-05
00380740174903AlinityAbbott Ireland DiagnosticsDDR2019-07-08
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