Catalog Number

83-0008-71

Brand Name

EliA ANCA/GBM Positive Control 2500/5000

Version/Model Number

83-0008-71

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

K173792,K173792

Product Code

MOB

Product Code Name

TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)

Public Device Record Key

685af87f-6c13-40be-9b3b-7804ff3a8fd1

Public Version Date

December 17, 2020

Public Version Number

1

DI Record Publish Date

December 09, 2020

Package DI Number

07333066014166

Quantity per Package

6

Contains DI Package

07333066013152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-