Catalog Number

PRD-04484

Brand Name

Panther Fusion

Version/Model Number

GBS KIT, 96T, IVD

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

Yes

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

NJR

Product Code Name

Nucleic acid amplification assay system, group b streptococcus, direct specimen test

Public Device Record Key

a8e8df8f-64b4-4124-8109-58ea72deee96

Public Version Date

August 07, 2019

Public Version Number

1

DI Record Publish Date

July 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-