Catalog Number

AND-300 I

Brand Name

ANA (HEp-2) Test System, 300 Tests

Version/Model Number

AND-300 I

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K872845

Product Code

DHN

Product Code Name

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

090f5971-5167-406c-ae38-c8f99045ee79

Public Version Date

March 04, 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

-