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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Sunquest Laboratory - B236LAB11020

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via user defined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
11.0.2
Not in Commercial Distribution

  • B236LAB11020 ()


  • Clinical laboratory information system application software

Sunquest Instrument Interfacing - B236IX3200

Sunquest Instrument Interfacing provides interfaces between laboratory instruments and Sunquest products.
CliniSys, Inc
3.2
Not in Commercial Distribution

  • B236IX3200 ()


  • Clinical laboratory information system application software

Sunquest Application Manager - B236SAM7120

Sunquest Application Manager (SAM) supports laboratories in the management of laboratory workflow (order entry through reporting) and to transfer test results and information.
CliniSys, Inc
7.1.2
Not in Commercial Distribution

  • B236SAM7120 ()


  • Clinical laboratory information system application software

Sunquest Application Manager - B236SAM7110

Sunquest Application Manager (SAM) supports laboratories in the management of laboratory workflow (order entry through reporting) and to transfer test results and information.
CliniSys, Inc
7.1.1
Not in Commercial Distribution

  • B236SAM7110 ()


  • Clinical laboratory information system application software

Sunquest Mitogen LIMS - B236LIMS4100

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.
CliniSys, Inc
4.1
Not in Commercial Distribution

  • B236LIMS4100 ()


  • Clinical laboratory information system application software

Sunquest Mitogen LIMS - B236LIMS4000

Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.
CliniSys, Inc
4.0
Not in Commercial Distribution

  • B236LIMS4000 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB11010

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via user defined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
11.0.1
Not in Commercial Distribution

  • B236LAB11010 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB11000

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via user defined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
11.0
Not in Commercial Distribution

  • B236LAB11000 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB10100

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
10.1
Not in Commercial Distribution

  • B236LAB10100 ()


  • Clinical laboratory information system application software

Sunquest Laboratory - B236LAB10000

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data
CliniSys, Inc
10.0
Not in Commercial Distribution

  • B236LAB10000 ()


  • Clinical laboratory information system application software
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