Catalog Number

1852132

Brand Name

US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each

Version/Model Number

1852132

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

ce987143-d0e0-4372-a0b4-c0708ae792df

Public Version Date

October 05, 2018

Public Version Number

3

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-