Catalog Number

DECC056000

Brand Name

EliA RF IgM Well

Version/Model Number

DECC056000

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

K102673,K102673

Product Code

DHR

Product Code Name

SYSTEM, TEST, RHEUMATOID FACTOR

Public Device Record Key

945ce239-95d2-4e3c-b60e-ec2bc7ee8a37

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

07333066010854

Quantity per Package

4

Contains DI Package

07333066014814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-