Catalog Number

-

Brand Name

Mission Saliva Test Strips

Version/Model Number

C031-021

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093879,K093879,K093879

Product Code

DIC

Product Code Name

ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Public Device Record Key

96e37f4c-a20f-4aa8-8822-24304df923e0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

20682607200058

Quantity per Package

80

Contains DI Package

00682607200054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton