Duns Number:008254708
Device Description: CD, Labpro V4.42 Panel Update-07LabPro V4.42 Panel Update-07 Kit (US, OUS)LabPro V4.42 Sys CD, Labpro V4.42 Panel Update-07LabPro V4.42 Panel Update-07 Kit (US, OUS)LabPro V4.42 System Kit wPanel Update-07 (US,OUS)
Catalog Number
-
Brand Name
MicroScan
Version/Model Number
V4.42
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LON
Product Code Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Public Device Record Key
b7abe10d-e813-4817-aaef-365efce2f374
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
July 06, 2018
Package DI Number
15099590703110
Quantity per Package
1
Contains DI Package
15099590703271
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |