Catalog Number

12000667

Brand Name

Bio-Rad Laboratories, Inc.

Version/Model Number

12000667

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

K780899

Product Code

DHN

Product Code Name

ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

Public Device Record Key

8d8d7da3-27cb-4b20-b0b2-97774a5bc094

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-