Catalog Number

NC-200025

Brand Name

ASI Sickle Cell Test

Version/Model Number

NC-200025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

GHM

Product Code Name

Test, Sickle Cell

Public Device Record Key

0add7dda-92d8-482a-8b15-f6fe3564878c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-