Catalog Number

GBSIDR-10

Brand Name

Staph ID/R Blood Culture Panel

Version/Model Number

GBSIDR-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

44f2789a-d3ac-42f9-b8b8-8301106e4e3c

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

B178GBSIDR102

Quantity per Package

10

Contains DI Package

B178GBSIDR100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box