Catalog Number

-

Brand Name

Anti-Legionella pneumophila ELISA (IgM)

Version/Model Number

EI 2150-9601 M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 13, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MJH

Product Code Name

Legionella, Spp., Elisa

Public Device Record Key

84a7e33c-64fd-47e5-89b2-00686b96e30d

Public Version Date

August 15, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-