Catalog Number

USA-LPH013

Brand Name

Cytocell Aquarius

Version/Model Number

USA-LPH013

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

DEN170070

Product Code

QDI

Product Code Name

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Public Device Record Key

b7e1d70d-3a94-4733-86d8-28d6b8ea1f3a

Public Version Date

January 15, 2020

Public Version Number

3

DI Record Publish Date

January 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-