Catalog Number

08056714190

Brand Name

Albumin Gen.2

Version/Model Number

08056714190

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

K033009

Product Code

CIX

Product Code Name

BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Public Device Record Key

29572c55-6d96-4089-a153-ec3789a5e29e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-