Catalog Number

23038062

Brand Name

Sure-Vue

Version/Model Number

T3018-4012

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

K954920,K954920

Product Code

LQN

Product Code Name

LATEX AGGLUTINATION ASSAY, RUBELLA

Public Device Record Key

d9ac0f12-7579-4964-9ab6-b4580fd7e15d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-