PCA(RS)48 Test(L) 4048L

GUDID 00813545022600

SCIMEDX CORPORATION

Parietal cell antibody IVD, kit, fluorescent immunoassay Parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00813545022600
• NIH Device Record Key: 1fcf03fa-43b3-4599-9ece-1b1f5a253234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCA(RS)48 Test(L)
• Version Model Number: 4048L
• Catalog Number: 4048L
• Company DUNS: 155424708
• Company Name: SCIMEDX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00813545022600 [Primary]

FDA Product Code

• DBJ: Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

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
• 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)