Catalog Number

790-20016-RF

Brand Name

BioArray Assay Imaging System TM (AIS) 400D

Version/Model Number

790-20016-RF

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK150270

Product Code

NSU

Product Code Name

Instrumentation For Clinical Multiplex Test Systems

Public Device Record Key

b1197aaf-1e02-4a7f-88ad-0b1af738baa4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-