Catalog Number

12001442

Brand Name

BioPlex 2200

Version/Model Number

4.3_v5

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

-

Product Code

MZF

Product Code Name

Test, Hiv Detection

Public Device Record Key

4bfcb9f8-1622-439e-bf14-a483c3780af8

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

February 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-