Catalog Number

-

Brand Name

AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360

Version/Model Number

AIA-360

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

-

Product Code

KHO

Product Code Name

Fluorometer, For Clinical Use

Public Device Record Key

a9eeae2d-b5e0-40d1-b59e-0f63824de4c2

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

September 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-