APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips.

APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips.
APIWEB™ - 1.4

An in vitro diagnostic interpretive software program intended to be used to aid the identification of infectious microbial species [bacterial, fungal, viral] in a clinical specimen using images from microbial cultures and laboratory biochemical tests (e.g., digital profiles), or by genetic profiling via nucleic acid analysis. Results from in vitro diagnostic tests are input and the presumptive name(s), probability of possible microbial species, and/or information on genetic variants (e.g., subtype, genotype, strain) are returned.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OUG

Device Name: Medical Device Data System

Device Class: 1

Physical State: Software and Electronics

Definition: A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Software algorithms to perform necessary medical communication functions

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Hospital Information Systems

Regulation Number: 880.6310

Third Party Flag: N

Medical Specialty: HO

Device Id: 03573026133542

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A