Catalog Number

-

Brand Name

Simplexa™ Group A Strep Positive Control Pack

Version/Model Number

MOL2860

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

K143651

Product Code

PGX

Product Code Name

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Public Device Record Key

96d6dc4e-16f5-42d3-9ce0-12e782b05bfd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-