Catalog Number

-

Brand Name

Human C1 Inactivator BINDARID™ Radial Immunodiffusion Kit

Version/Model Number

RN019.3

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K915431

Product Code

DBA

Product Code Name

Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

Public Device Record Key

d5dd3d0a-1369-41fa-8233-2324ecac734a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-