Catalog Number

294753

Brand Name

NA

Version/Model Number

294753

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

-

Product Code

LHL

Product Code Name

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

Public Device Record Key

ce9d8bd5-e27a-4b57-ad61-a08379385ab1

Public Version Date

March 31, 2020

Public Version Number

3

DI Record Publish Date

June 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-