Catalog Number

-

Brand Name

QUANTA Flash® B2GP1 IgA Reagents

Version/Model Number

701240

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120817

Product Code

MSV

Product Code Name

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Public Device Record Key

5fd11fe2-511d-47a6-af31-b7ca15625d8a

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

September 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-