Catalog Number

-

Brand Name

M45b Test Reagent 2-15

Version/Model Number

M45b

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

-

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

LHL

Product Code Name

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

Public Device Record Key

ec9b42a1-3c98-48fa-a659-389e6642c381

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-