Catalog Number

-

Brand Name

SpeciMAX Dx Saliva Collection Kit

Version/Model Number

A51022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDT

Product Code Name

CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Public Device Record Key

2ad6e7b9-6f02-4525-9fd1-853344500417

Public Version Date

April 21, 2022

Public Version Number

1

DI Record Publish Date

April 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-