Duns Number:008254708
Device Description: LabPro Connect software is an option for laboratories with multiple instruments and workst LabPro Connect software is an option for laboratories with multiple instruments and workstations in a networked environment to improve workflow efficiency, data processing and storage, and to increase throughput. With LabPro Connect software, you can access all results data from any MicroScan instrument on the LabPro network and perform most daily tasks (for example, ordering panels, printing barcode labels, viewing panel results, resolving panel processing alerts, and transmitting test results).
Catalog Number
C24147
Brand Name
MicroScan
Version/Model Number
V5.0
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
K201405,K201405
Product Code
LON
Product Code Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Public Device Record Key
227214b6-dad0-4cec-92ec-81ba9ecee641
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
October 23, 2020
Package DI Number
15099590702793
Quantity per Package
1
Contains DI Package
15099590702724
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
padded envelope
| 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 |