Catalog Number

QSI-0500

Brand Name

Quantisal

Version/Model Number

QSI-0500

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200801

Product Code

PJD

Product Code Name

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Public Device Record Key

46735d87-43c5-4f90-9f71-643166877d98

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-