Catalog Number

-

Brand Name

Hevylite® Human IgM Lambda Kit for use on the SPAPLUS

Version/Model Number

NK626.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

K140686

Product Code

PDF

Product Code Name

Immunoglobulin M Lambda Heavy And Light Chain Combined

Public Device Record Key

14e4f529-244e-45f8-aa4e-5f55b8e2c6b1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-