Catalog Number

1840380

Brand Name

MBT Biotarget 96 US IVD

Version/Model Number

1840380

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

K163536,K163536

Product Code

PEX

Product Code Name

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

Public Device Record Key

9e6d7d01-ad65-45b7-9938-db6596cad0f8

Public Version Date

October 05, 2018

Public Version Number

4

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-