Catalog Number

NC355001

Brand Name

ASI SLE Slide Test Control Set

Version/Model Number

NC-355001

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

K821385

Product Code

DHC

Product Code Name

System, Test, Systemic Lupus Erythematosus

Public Device Record Key

a00f603f-e951-4a06-8ccb-2f4cd453b3f3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-