Silaris RSV Control Kit - The Silaris RSV Control Kit is intended for in - MESA BIOTECH, INC.

Duns Number:056865474

Device Description: The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control tes The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test

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More Product Details

Catalog Number

1029

Brand Name

Silaris RSV Control Kit

Version/Model Number

1029

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

OCC

Product Code Name

Respiratory Virus Panel Nucleic Acid Assay System

Device Record Status

Public Device Record Key

68e891c1-7374-4098-889a-6b51fbfa8ba6

Public Version Date

August 06, 2019

Public Version Number

1

DI Record Publish Date

July 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MESA BIOTECH, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11