Catalog Number

3333701190

Brand Name

Alkaline Phosphatase acc to IFCC Gen2

Version/Model Number

3333701190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K033185

Product Code

CJE

Product Code Name

NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Public Device Record Key

bce6cbe8-f1f5-4d8c-97cd-9495a05f3929

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-