Catalog Number

GEN-ALP R2

Brand Name

GENCHEM™ Alkaline Phosphatase

Version/Model Number

GEN-ALP R2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CJE

Product Code Name

NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Public Device Record Key

7e6cf02a-c124-4895-aa85-26c9970bc48d

Public Version Date

October 21, 2022

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-