Catalog Number

72938

Brand Name

Bio-Rad Platelia

Version/Model Number

72938

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

K973123

Product Code

LSE

Product Code Name

Epstein-Barr Virus, Other

Public Device Record Key

06a3c67b-c505-4a9f-ba5f-fc8efc9fd70d

Public Version Date

November 22, 2019

Public Version Number

1

DI Record Publish Date

November 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-