Catalog Number

-

Brand Name

ASI IVD System

Version/Model Number

GenASIs 8.3

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

K140957,K122554,K110345,K012103,K101291,K071398,K050236

Product Code

JOY

Product Code Name

Device, Automated Cell-Locating

Public Device Record Key

f23220a8-c124-4226-a514-1764ebfbe01c

Public Version Date

March 29, 2022

Public Version Number

1

DI Record Publish Date

March 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-