Catalog Number

662879

Brand Name

FACS

Version/Model Number

662879

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

K170974

Product Code

OYE

Product Code Name

Flow cytometric reagents and accessories.

Public Device Record Key

a05905ac-ffdc-4f9b-9a56-604c63cf0dd1

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

October 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-