Catalog Number

83-0008-81

Brand Name

EliA CCP Positive Control 2500/5000

Version/Model Number

83-0008-81

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

K061165,K061165

Product Code

NHX

Product Code Name

ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

Public Device Record Key

5da97d73-47b9-4487-a9f3-88698c45723f

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Package DI Number

07333066014173

Quantity per Package

6

Contains DI Package

07333066020020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-