Catalog Number

83-0008-51

Brand Name

EliA IgM Conjugate 200

Version/Model Number

83-0008-51

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

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

K182747,K182747

Product Code

DHR

Product Code Name

SYSTEM, TEST, RHEUMATOID FACTOR

Public Device Record Key

791d0cb9-92e5-443e-91cb-80f305131b24

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Package DI Number

07333066014135

Quantity per Package

6

Contains DI Package

07333066013138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-