Catalog Number

PRD-07041

Brand Name

APTIMA

Version/Model Number

PANTHER,TRICH REFRIG,V2,250T,READY MADE

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

K200436

Product Code

OUY

Product Code Name

Trichomonas vaginalis nucleic acid amplification test system

Public Device Record Key

1babaf64-5e22-4d76-a70f-93fe0c5de954

Public Version Date

August 05, 2022

Public Version Number

1

DI Record Publish Date

July 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-