BIOMIC

Basic Information

• Brand Name: BIOMIC
• Primary DI: 00863504000217
• Version / Model: V3
• Catalog Number: BV3
• Company Name: Giles Scientific, Inc.
• Labeler DUNS: 144629342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-21
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 09ddd1c0-e81b-4aae-9f3b-ca7b2cbcca7f
• Distribution End Date: 2050-01-01

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZK	Reader, Zone, Automated	Microbiology	866.2850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65229	Antimicrobial susceptibility/resistance testing interpretive software IVD	An in vitro diagnostic software program intended to be used for the interpretation of results of an in vitro diagnostic assay [e.g., minimum inhibitory concentration (MIC), mass spectrometry (MALDI-TOF)] performed on a microbial culture isolated from a clinical specimen, to determine the susceptibility, intermediate or resistance categorization of the microbial species. It is installed on an off-the-shelf computer or a web-based platform, and compares assay results (e.g., an acquired image, mass spectrum) to reference data to determine antimicrobial resistance (e.g., beta-lactamase, carbapenamase, and/or cephalosporinase activity). Results are used to guide patient treatment options.	No	Active
46333	Colony counter IVD, automated/semi-automated	A mains electricity (AC-powered) automated or semi-automated laboratory device designed to count bacterial colonies in a culture. It typically consists of a sample container (e.g., Petri dish, pour or spiral plate, culture flask), appropriate light sources, a camera and/or microscope, a display, and dedicated software. The device may be used to count microorganisms in different colony configurations – separating, highlighting, and making computerized counts of the colonies. It may also perform zone measuring (e.g., for antibacterial susceptibility tests) and/or additional tests that may include particle counting, such as cell tests for mutagenicity (i.e., Ames tests).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863504000217	GS1