Catalog Number

83-0007-01

Brand Name

EliA ANCA/GBM Positive Control 100

Version/Model Number

83-0007-01

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

K140225,K140225

Product Code

JJY

Product Code Name

Multi-analyte controls, all kinds (assayed)

Public Device Record Key

55c7eb27-f3a1-413c-8055-0d6e10cec7b8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

07333066013886

Quantity per Package

6

Contains DI Package

07333066013053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-