Catalog Number

NC-600500E

Brand Name

ASI Rubella Test

Version/Model Number

NC-600500E

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

K031490

Product Code

LQN

Product Code Name

Latex Agglutination Assay, Rubella

Public Device Record Key

550734e3-bee5-449f-89cb-4b02c6536560

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-