Catalog Number

-

Brand Name

IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

Version/Model Number

FC 1572-2005

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

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

K172244

Product Code

KTL

Product Code Name

Anti-Dna Indirect Immunofluorescent Solid Phase

Public Device Record Key

7427a728-1bde-44c9-921e-eef8574c022d

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-