Catalog Number

-

Brand Name

ABX PENTRA ALP CP

Version/Model Number

1220001626

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

-

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

-

FDA Premarket Submission

K060205

Product Code

CJE

Product Code Name

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Public Device Record Key

fff8d706-58d5-4941-b23a-f676a950a5d9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-