Nano-CheckTM Nicotine - 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 Cotinine in human urine

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More Product Details

Catalog Number

AD6083

Brand Name

Nano-CheckTM Nicotine

Version/Model Number

AD6083

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

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

793833f7-b362-4dea-a4bc-bf0ba44eae1d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-