Catalog Number

-

Brand Name

IDS-iSYS Ostase® BAP

Version/Model Number

IS-2800US

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

K200475

Product Code

CIN

Product Code Name

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Public Device Record Key

0c935c8d-c7ee-4d47-abb9-ae656d1eb3ec

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

March 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-