Catalog Number

-

Brand Name

Hevylite Human IgG Kappa Kit for use on the SPAPLUS

Version/Model Number

NK621.S.A

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

K161854

Product Code

PCN

Product Code Name

Immunoglobulin G Kappa Heavy And Light Chain Combined

Public Device Record Key

37dc76f7-ee79-4b89-8ebe-bb5faab3ddba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-