Catalog Number

-

Brand Name

Optilite Rheumatoid Factor Kit

Version/Model Number

LK151.OPT.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

K162263

Product Code

DHR

Product Code Name

System, Test, Rheumatoid Factor

Public Device Record Key

996042e3-99af-4bb3-85e7-4b7f2fe6ad28

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-