Catalog Number

8604784

Brand Name

MALDI Biotyper - smart CA

Version/Model Number

8604784

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)

Yes

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

e175690f-36a6-46cc-a953-bf6a249bd240

Public Version Date

September 26, 2022

Public Version Number

4

DI Record Publish Date

February 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-