CliniSys, Inc

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2029302	1000306472	CliniSys, Inc	1	N	2026-01-01	3300 E. Sunrise Dr. TUCSON AZ US 85718

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission
14979	2044167689	BK160005
14979	1196887027	BK040065
14979	1561635712
14979	1806195960

GUDID#

Clinisys CoPathPlus - The intended use of Clinisys CoPathPlus is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. This product is intended for use by trained health care and laboratory professionals.

CliniSys, Inc

2026-02-18

Clinisys SQ Blood Bank - Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2026-01-23

Clinisys SQ Lab - Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory.Clinisys SQ Lab is intended for use only by professionals who have received extensivetraining in the use of the software. Clinisys SQ Lab is controlled via user defined securitylevels, 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

2026-01-23

Clinisys Atlas - Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Clinisys Physician Portal• Clinisys Advanced EMR Connectivity• Clinisys Patient Service Center (PSC) Portal• Clinisys Multi-Lab Networking

CliniSys, Inc

2026-01-06

Clinisys Laboratory Solution - The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.

CliniSys, Inc

2025-11-10

Clinisys Laboratory Solution - The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.

CliniSys, Inc

2025-08-13

Clinisys Atlas - Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Clinisys Physician Portal• Clinisys Advanced EMR Connectivity• Clinisys Patient Service Center (PSC) Portal• Clinisys Multi-Lab Networking

CliniSys, Inc

2025-07-11

Sunquest Blood Bank - Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2022-03-22

Sunquest Laboratory - 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

2022-03-22

Sunquest Blood Bank - Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2021-03-05

Sunquest Laboratory - 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

2021-03-05

Sunquest Blood Bank - Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2021-02-19

Sunquest Blood Bank - Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2021-02-19

Sunquest Blood Bank - Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2021-02-19

Sunquest Laboratory - 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

2021-02-19

Sunquest Laboratory - 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

2021-02-19

Sunquest Laboratory - 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

2021-02-19

Clinisys SQ Blood Bank - Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2024-12-06

Clinisys SQ Lab - Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory.Clinisys SQ Lab is intended for use only by professionals who have received extensivetraining in the use of the software. Clinisys SQ Lab is controlled via user defined securitylevels, 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

2024-12-06

Clinisys Atlas - Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Clinisys Physician Portal• Clinisys Advanced EMR Connectivity• Clinisys Patient Service Center (PSC) Portal• Clinisys Multi-Lab Networking

CliniSys, Inc

2024-11-27

Clinisys Laboratory Solution - The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.

CliniSys, Inc

2024-10-25

Clinisys Laboratory Solutions - The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.

CliniSys, Inc

2024-03-18

Clinisys Laboratory Solutions - The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.

CliniSys, Inc

2024-08-12

Clinisys Laboratory Solutions - The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.

CliniSys, Inc

2024-05-02

Clinisys Laboratory Solutions - The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.

CliniSys, Inc

2023-07-06

Sunquest Blood Bank - Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2023-06-21

Sunquest Laboratory - 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 extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, 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

2023-06-21

Clinisys Atlas - Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Clinisys Physician Portal• Clinisys Advanced EMR Connectivity• Clinisys Patient Service Center (PSC) Portal• Clinisys Multi-Lab Networking

CliniSys, Inc

2024-05-02

Clinisys SQ Blood Bank - Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2024-03-10

Clinisys SQ Lab - Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory.Clinisys SQ Lab is intended for use only by professionals who have received extensivetraining in the use of the software. Clinisys SQ Lab is controlled via user defined securitylevels, 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

2024-03-10

Clinisys Atlas - Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Clinisys Physician Portal• Clinisys Advanced EMR Connectivity• Clinisys Patient Service Center (PSC) Portal• Clinisys Multi-Lab Networking

CliniSys, Inc

2023-12-01

Sunquest Mitogen LIMS - 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

2022-08-05

Sunquest Atlas - Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of our clients. All four solutions are supported with the same core platform.• Sunquest Physician Portal• Sunquest Advanced EMR Connectivity• Sunquest Patient Service Center (PSC) Portal• Sunquest Multi-Lab Networking

CliniSys, Inc

2023-07-21

Sunquest Blood Bank - Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.

CliniSys, Inc

2022-11-03

Sunquest Laboratory - 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 extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, 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

2022-11-03

Sunquest CoPathPlus - Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information..

CliniSys, Inc

2020-11-12

Sunquest Instrument Interfacing - Sunquest Instrument Interfacing provides interfaces between laboratory instruments and Sunquest products.

CliniSys, Inc

2020-11-12

Sunquest Blood Bank - Sunquest Blood Bank System

CliniSys, Inc

2019-11-23

Sunquest Mitogen LIMS - 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

2020-11-12

Sunquest Mitogen LIMS - 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

2021-04-20

68 records. Showing 1-40. Next