BIOMIC BV3

GUDID 00863504000217

Giles Scientific, Inc.

Microbial susceptibility testing interpretive software IVD

• Primary Device ID: 00863504000217
• NIH Device Record Key: 09ddd1c0-e81b-4aae-9f3b-ca7b2cbcca7f
• Commercial Distribution Discontinuation: 2050-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMIC
• Version Model Number: V3
• Catalog Number: BV3
• Company DUNS: 144629342
• Company Name: Giles Scientific, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	00863504000217 [Primary]

FDA Product Code

• KZK: Reader, Zone, Automated

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-29
• Device Publish Date: 2023-03-21