Catalog Number

3004902122

Brand Name

Tina-quant RF II

Version/Model Number

3004902122

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2018

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

Yes

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

K032535

Product Code

DHR

Product Code Name

SYSTEM, TEST, RHEUMATOID FACTOR

Public Device Record Key

a55834d9-6fff-4162-aa9f-e24a4eca3c06

Public Version Date

November 11, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-