Catalog Number

9541

Brand Name

CELLTRACKS AUTOPREP

Version/Model Number

9541

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

K122821

Product Code

NQI

Product Code Name

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

Public Device Record Key

2efa8255-9c11-4d52-bb3d-1bc5bfb7975d

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

July 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-