Catalog Number

-

Brand Name

Shineway

Version/Model Number

SWSI-02

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OOI

Product Code Name

Real Time Nucleic Acid Amplification System

Public Device Record Key

a012c56c-0fc1-47fc-a052-6ef9f304c055

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 09, 2022

Package DI Number

26974900600104

Quantity per Package

20

Contains DI Package

16974900600091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box