Nano-CheckTM AMI cTnI - In Vitro Diagnostic Test kit for the detection of - NANO-DITECH CORPORATION

Duns Number:126544316

Device Description: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and pl In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma

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More Product Details

Catalog Number

CD7141

Brand Name

Nano-CheckTM AMI cTnI

Version/Model Number

CD7141

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102131,K102131

Product Code Details

Product Code

MMI

Product Code Name

Immunoassay Method, Troponin Subunit

Device Record Status

Public Device Record Key

1a9f3bc0-9ed4-4a0e-931d-7e2253521b57

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-