PR3 IgG Test System PR3396

GUDID 00813545029043

SCIMEDX CORPORATION

Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00813545029043
• NIH Device Record Key: fd934edd-1ee0-4152-a74c-895f816ca73d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PR3 IgG Test System
• Version Model Number: PR3396
• Catalog Number: PR3396
• Company DUNS: 155424708
• Company Name: SCIMEDX CORPORATION
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813545029043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954105

FDA Product Code

• MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by SCIMEDX CORPORATION

• 00813545023843 - ProSorb-G 2 ml 50 Test: 2023-06-21 IgG Removal Reagent
• 00813545029029 - GBM IgG Test System: 2023-06-21
• 00813545029036 - MBO IgG Test System: 2023-06-21
• 00813545029043 - PR3 IgG Test System: 2023-06-21
• 00813545029043 - PR3 IgG Test System: 2023-06-21
• 00813545026561 - MeDiCa: 2020-12-09 Rat Liver 4 Well Slide (each)
• 00813545026578 - MeDiCa: 2020-12-09 Rat Liver 8 Well Slide (each)
• 00813545026585 - MeDiCa: 2020-12-09 Crithidia luciliae 4 Well Slide (each)
• 00813545026592 - MeDiCa: 2020-12-09 Crithidia luciliae 8 Well Slide (each)