Catalog Number

6651160H

Brand Name

BioPlex 2200

Version/Model Number

SW4.1_V2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2019

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

-

Product Code

LJM

Product Code Name

ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS

Public Device Record Key

4a16d1fd-7dc7-4271-92c0-0dc3bfefc020

Public Version Date

November 07, 2019

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-