Sunquest Mitogen Genetics

GUDID B236SMG6300

Sunquest Mitogenâ„¢ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.

SUNQUEST INFORMATION SYSTEMS, INC.

Human genomic analysis interpretive software

• Primary Device ID: B236SMG6300
• NIH Device Record Key: 562453c2-2465-4b50-970a-ec5fa0fd68ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunquest Mitogen Genetics
• Version Model Number: 6.3
• Company DUNS: 052934841
• Company Name: SUNQUEST INFORMATION SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B236SMG6300 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-23
• Device Publish Date: 2020-11-12

Devices Manufactured by SUNQUEST INFORMATION SYSTEMS, INC.

• B236LIMS4100 - Sunquest Mitogen LIMS: 2022-08-15 Sunquest Mitogenâ„¢ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting)
• B236BB11000 - Sunquest Blood Bank: 2022-07-01 Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: â€
• B236LAB11000 - Sunquest Laboratory: 2022-07-01 Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for u
• B236ATL202210 - Sunquest Atlas: 2022-04-22 Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
• B236PWP13000 - Sunquest PowerPath: 2022-04-22 The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (o
• B236CPP8000 - Sunquest CoPathPlus: 2022-04-05 Sunquest CoPathPlus supports anatomic pathology laboratories in the management of laboratory workflow (order entry through repor
• B236BB10110 - Sunquest Blood Bank: 2022-03-30 Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intende
• B236LAB10110 - Sunquest Laboratory: 2022-03-30 Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The system is marketed as an automate