Catalog Number

12006557

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MRG

Product Code Name

SYSTEM, TEST, VITAMIN D

Public Device Record Key

b77b3ba6-fa0d-4a83-a0aa-2d18b395ecb5

Public Version Date

September 27, 2018

Public Version Number

1

DI Record Publish Date

August 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-