Catalog Number

FDNA100

Brand Name

DIASTAT anti-dsDNA

Version/Model Number

FDNA100

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

K905386

Product Code

KTL

Product Code Name

Anti-Dna Indirect Immunofluorescent Solid Phase

Public Device Record Key

0e1e6c3a-dc8d-4f65-82b1-8c2182f550f1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-