Catalog Number

MOL2750

Brand Name

Simplexa™ Bordetella Direct

Version/Model Number

MOL2750

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 2018

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

OZZ

Product Code Name

Bordetella Pertussis Dna Assay System

Public Device Record Key

9e7709be-0d1d-4f9c-bb55-ef8686019cc7

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-