PBC Separator with Selux AST System

GUDID 00850031114067

Selux Diagnostics, Inc.

Antimicrobial susceptibility analyser IVD

• Primary Device ID: 00850031114067
• NIH Device Record Key: 2fd68164-2b0d-4285-b408-1cf168cb1e1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PBC Separator with Selux AST System
• Version Model Number: 02-10001
• Company DUNS: 079715313
• Company Name: Selux Diagnostics, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850031114067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223493

FDA Product Code

• LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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: 2024-12-30
• Device Publish Date: 2024-12-20

Devices Manufactured by Selux Diagnostics, Inc.

• 00195893563760 - Selux AST System: 2024-12-30
• 00850031114005 - Bulk Analyzer Reagent Pack: 2024-12-30
• 10850031114026 - Selux AST Gram Negative Panel: 2024-12-30
• 00850031114036 - AST Inoculator: 2024-12-30
• 00850031114043 - AST Analyzer: 2024-12-30
• 00850031114067 - PBC Separator with Selux AST System: 2024-12-30
• 00850031114067 - PBC Separator with Selux AST System: 2024-12-30
• 10850031114149 - Selux Seaparator Reagent Kit: 2024-12-30
• 00850031114135 - Selux AST Gram Positive Panels: 2024-12-25