Catalog Number

8603464

Brand Name

MALDI Biotyper CA System

Version/Model Number

8603464

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2019

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

PEX

Product Code Name

System, mass spectrometry, maldi tof, microorganism identification, cultured isolates

Public Device Record Key

d2efb568-2e50-4a7c-a5de-a7346ec17904

Public Version Date

September 26, 2022

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-