Catalog Number

12000657

Brand Name

BioPlex 2200

Version/Model Number

4.3_v1

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

GMQ

Product Code Name

ANTIGENS, NONTREPONEMAL, ALL

Public Device Record Key

f2122946-3790-47cd-9c9c-c28fc287bf45

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-