Catalog Number

GP104X

Brand Name

WIESLAB anti-GBM semi quantitative kit

Version/Model Number

GP104X

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

K974169

Product Code

DBL

Product Code Name

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

e98876f7-2131-492d-9d02-bc3d332ef8e6

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

-