Catalog Number

08N16-001

Brand Name

VP2000

Version/Model Number

08N16-001

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

P110012

Product Code

OWE

Product Code Name

Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

Public Device Record Key

4308c716-e1c6-4a2c-8281-1a50d6cfd3d2

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

July 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-