Catalog Number

M313

Brand Name

Solana SARS-CoV-2 Assay

Version/Model Number

Coronavirus

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

-

Product Code

QJR

Product Code Name

Reagents, 2019-novel coronavirus nucleic acid

Public Device Record Key

7d9faf9a-d49d-4196-8411-cb276990f79d

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-