Catalog Number

-

Brand Name

Genabio

Version/Model Number

BP291-1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

QKP

Product Code Name

Coronavirus Antigen Detection Test System.

Public Device Record Key

2eb380a0-335d-4e3e-94ef-8e17770a3658

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

16942468181673

Quantity per Package

240

Contains DI Package

06942468181676

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton