Catalog Number

RG-M7613-D

Brand Name

BP 230 ELISA TEST

Version/Model Number

RG-M7613-D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 26, 2020

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

-

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

K071961

Product Code

OEG

Product Code Name

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

Public Device Record Key

8f8eb0db-2f32-4bcb-9f5a-a0eb52b8415b

Public Version Date

June 18, 2020

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-