Clinisys Laboratory Solution

GUDID B236CLS202330

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

Clinical laboratory information system application software
Primary Device IDB236CLS202330
NIH Device Record Key51033b0b-69b1-4705-9823-4c963cba6d05
Commercial Distribution StatusIn Commercial Distribution
Brand NameClinisys Laboratory Solution
Version Model Number2023.3
Company DUNS052934841
Company NameCliniSys, Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB236CLS202330 [Primary]

FDA Product Code

JQPCalculator/Data Processing Module, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-04
Device Publish Date2024-10-25

Devices Manufactured by CliniSys, Inc

B236SQBB202410 - Clinisys SQ Blood Bank2024-12-16 Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: â€
B236SQLAB202410 - Clinisys SQ Lab2024-12-16 Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only
B236CATL202340 - Clinisys Atlas2024-12-05 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
B236CLS202330 - Clinisys Laboratory Solution2024-11-04The 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.
B236CLS202330 - Clinisys Laboratory Solution2024-11-04 The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The
B236CLS202320 - Clinisys Laboratory Solutions2024-08-20 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th
B236CATL202330 - Clinisys Atlas2024-05-10 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
B236CLS2023200 - Clinisys Laboratory Solutions2024-05-10 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th
B236CLS20232140 - Clinisys Laboratory Solutions2024-03-26 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th

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