Catalog Number

-

Brand Name

Human IgM kit for use on SPAPLUS

Version/Model Number

NK012.S

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

K082129,K191465

Product Code

CFN

Product Code Name

Method, Nephelometric, Immunoglobulins (G, A, M)

Public Device Record Key

c35990d8-4583-48b8-a960-8d54b12d9f0b

Public Version Date

July 03, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-