MicroScan LabPro Information Manager System

ivd

Version 1.0 to Version 4.11

General Hospital and Personal Use Devices

1

No

Worldwide distribution: United States (including Puerto Rico), Bahamas, Belgium, Canada, Chile, China, Colombia, France, French Guiana, Germany, Greece, Guadeloupe, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Turkey, , US Virgin Islands, and Northern Mariana Islands, Uruguay.

MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).

not applicable

General Hospital and Personal Use Devices

1

No

Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.

MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 || Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. || Japan: || 10638819 LabPro v4.11 Software Update Kit || 10638820 LabPro v4.11 System Software || 10805072 LabPro MBT Non-Connect Systems v4.30 || 10805073 LabPro MBT Connect Systems v4.30 || Canada: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || Europe: || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || USA: || 10714149, LabPro v4.11 Software Update Kit || 10714150 LabPro v4.11 System Software || 10975000 ASM LabPro-MBT v4.40 || 10975001 ASM LabPro-MBT v4.40 for Connect || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || ROW: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || Product Usage: || LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.

In-vitro diagnostics

In-vitro diagnostics