Catalog Number

-

Brand Name

Anti-BP230-CF ELISA (IgG)

Version/Model Number

EA 1502-4801-1 G

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

K193115

Product Code

OEG

Product Code Name

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

Public Device Record Key

7c2c16af-3cb3-430d-aab4-08b396e931a8

Public Version Date

October 06, 2020

Public Version Number

1

DI Record Publish Date

September 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-