SeptiCyte RAPID [US IVD]

GUDID 10860007612654

Sepsis Host Response US IVD EDTA PAXgene Variant Dispenser Box

Immunexpress Inc.

Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence

• Primary Device ID: 10860007612654
• NIH Device Record Key: 52a1da07-7dcd-4005-8497-afd755cfa03a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeptiCyte RAPID [US IVD]
• Version Model Number: SB3020U
• Company DUNS: 964789676
• Company Name: Immunexpress 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	10860007612654 [Primary]

FDA Product Code

• PRE: Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

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: 2024-03-25
• Device Publish Date: 2024-03-17

On-Brand Devices [SeptiCyte RAPID [US IVD]]

• 10860007612654: Sepsis Host Response US IVD EDTA PAXgene Variant Dispenser Box
• 00860007612657: Sepsis Host Response US IVD EDTA PAXgene Variant Cartridge