Catalog Number

GBSTEC-10

Brand Name

Shiga Toxin Direct Test

Version/Model Number

GBSTEC-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

OOI

Product Code Name

Real Time Nucleic Acid Amplification System

Public Device Record Key

61b9df43-2304-496f-805c-5e01058e9d64

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

B178GBSTEC102

Quantity per Package

10

Contains DI Package

B178GBSTEC100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box