Catalog Number

B1077-18

Brand Name

CARDINAL HEALTH

Version/Model Number

B1077-18

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)

Yes

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

K031490,K031490

Product Code

LQN

Product Code Name

LATEX AGGLUTINATION ASSAY, RUBELLA

Public Device Record Key

81ad2152-7faf-4c90-9e49-1011a2a9d154

Public Version Date

July 19, 2018

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-