Duns Number:318387958
Device Description: Workstation to disperse reagents onto clinical samples for use with MBT-CA System, for cli Workstation to disperse reagents onto clinical samples for use with MBT-CA System, for clinical use in USA
Catalog Number
1875054
Brand Name
MBT Galaxy System - US IVD
Version/Model Number
1875054
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
a8128175-52e3-47e8-a057-4f1c32ef7df1
Public Version Date
September 26, 2022
Public Version Number
2
DI Record Publish Date
February 11, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |