Catalog Number

07958021190

Brand Name

cobas PCR Media Dual Swab Sample Kit

Version/Model Number

07958021190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

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

-

FDA Premarket Submission

-

Product Code

LIO

Product Code Name

Device, specimen collection

Public Device Record Key

dad26b9d-9a88-40c2-9a93-3fd4695ff15b

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

June 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-