Catalog Number

B01-4121-01

Brand Name

ADVIA® Chemistry ALB Albumin BCG Reagents

Version/Model Number

10311832

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991576,K991576

Product Code

CIX

Product Code Name

BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Public Device Record Key

b6164aca-42e1-40bb-9194-f24651a661d5

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-