Catalog Number

83-0008-61

Brand Name

EliA ANA Positive Control 2500/5000

Version/Model Number

83-0008-61

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

K190710,K190710

Product Code

JJY

Product Code Name

Multi-analyte controls, all kinds (assayed)

Public Device Record Key

6aa5c700-9f03-45e6-bdc3-a67705b1f38d

Public Version Date

March 30, 2021

Public Version Number

2

DI Record Publish Date

November 20, 2020

Package DI Number

07333066014142

Quantity per Package

6

Contains DI Package

07333066013145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-