MeDiCa 0402

GUDID 00813545026653

Rat Stomach 8 Well Slide (each)

SCIMEDX CORPORATION

Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay Smooth muscle antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00813545026653
• NIH Device Record Key: 46ae2cf0-c8ff-4939-acf7-06ea10934960
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeDiCa
• Version Model Number: 0402
• Catalog Number: 0402
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813545026653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790430

FDA Product Code

• DBE: Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

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: 2020-12-09
• Device Publish Date: 2020-12-01

On-Brand Devices [MeDiCa]

• 00813545027605: Multi-Ab II Mouse (Kidney + Liver + Stomach) + Crithidia luciliae 96 Test Kit
• 00813545027599: Multi-Ab II Mouse (Kidney + Liver + Stomach) + Crithidia luciliae 48 Test Kit
• 00813545027582: Multi-Ab II Rat (Kidney + Liver + Stomach) + Crithidia luciliae 96 Test Kit
• 00813545027575: Multi-Ab II Rat (Kidney + Liver + Stomach) + Crithidia luciliae 48 Test Kit
• 00813545027568: Multi-Ab II Mouse (Kidney + Stomach) + Crithidia luciliae 96 Test Kit
• 00813545027551: Multi-Ab II Mouse (Kidney + Stomach) + Crithidia luciliae 48 Test Kit
• 00813545027544: Multi-Ab II Rat (Kidney + Stomach) + Crithidia luciliae 96 Test Kit
• 00813545027537: Multi-Ab II Rat (Kidney + Stomach) + Crithidia luciliae 48 Test Kit
• 00813545027520: Multi-Ab I Mouse (Kidney + Liver + Stomach) 400 Test Kit
• 00813545027513: Multi-Ab I Mouse (Kidney + Liver + Stomach) 400 Test Kit
• 00813545027506: Multi-Ab I Mouse (Kidney + Liver + Stomach) 200 Test Kit
• 00813545027490: Multi-Ab I Mouse (Kidney + Liver + Stomach) 96 Test Kit
• 00813545027483: Multi-Ab I Mouse (Kidney + Liver + Stomach) 48 Test Kit
• 00813545027476: Multi-Ab I Rat (Kidney + Liver + Stomach) 400 Test Kit
• 00813545027469: Multi-Ab I Rat (Kidney + Liver + Stomach) 4 Well 200 Test Kit
• 00813545027452: Multi-Ab I Rat (Kidney + Liver + Stomach) 96 Test Kit
• 00813545027445: Multi-Ab I Rat (Kidney + Liver + Stomach) 48 Test Kit
• 00813545027438: Multi-Ab I Rat (Kidney + Liver + Stomach) 96 Test Kit
• 00813545027421: Multi-Ab I Rat (Kidney + Liver + Stomach) 48 Test Kit
• 00813545027414: Multi-Ab I Rat (Kidney + Liver + Stomach) 1600 Test Kit
• 00813545027407: Multi-Ab I Rat (Kidney + Liver + Stomach) 400 Test Kit
• 00813545027391: Multi-Ab I Rat (Kidney + Liver + Stomach) 200 Test Kit
• 00813545027384: Multi-Ab I Rat (Kidney + Liver + Stomach) 96 Test Kit
• 00813545027377: Multi-Ab I Rat (Kidney + Liver + Stomach) 48 Test Kit
• 00813545027360: Multi-Ab III Mouse (Kidney + Stomach) 400 Test Kit
• 00813545027353: Multi-Ab III Mouse (Kidney + Stomach) 96 Test Kit
• 00813545027346: Multi-Ab III Mouse (Kidney + Stomach) 400 Test Kit
• 00813545027339: Multi-Ab III Mouse (Kidney + Stomach) 200 Test Kit
• 00813545027322: Multi-Ab III Mouse (Kidney + Stomach) 96 Test Kit
• 00813545027315: Multi-Ab III Mouse (Kidney + Stomach) 48 Test Kit
• 00813545027308: Multi-Ab III Rat (Kidney + Stomach) 4 & 8 well 96 Test Kit
• 00813545027292: Multi-Ab III Rat (Kidney + Stomach) 96 Test Kit
• 00813545027285: Multi-Ab III Rat (Kidney + Stomach) 200 Test Kit
• 00813545027278: Multi-Ab III (AMA, ASMA) Rat (Kidney + Stomach) 96 Test Kit
• 00813545027261: Multi-Ab III Rat (Kidney + Stomach) 400 Test Kit
• 00813545027223: Multi-Ab III Rat (Kidney + Stomach) 48 Test Kit
• 00813545027216: AEmA (anti-endomysial) Monkey Esophagus distal 48 Test Kit
• 00813545027179: ATA (anti-thyroid) Monkey Thyroid (thyroglobulin) 96 Test Kit
• 00813545027162: ATA (anti-thyroid) Monkey Thyroid (thyroglobulin) 48 Test Kit
• 00813545027155: ATA (anti-thyroid) Monkey Thyroid (microsomal) 96 Test Kit
• 00813545027148: ATA (anti-thyroid) Monkey Thyroid (microsomal) 48 Test Kit
• 00813545027131: ASA (anti-skin) Monkey Esophagus 96 Test Kit
• 00813545027124: ASA (anti-skin) Monkey Esophagus 48 Test Kit
• 00813545027117: AEmA (anti-endomysial) Monkey Esophagus distal 400 Test Kit
• 00813545027100: AEmA (anti-endomysial) Monkey Esophagus distal 96 Test Kit
• 00813545027094: AEmA (anti-endomysial) Monkey Esophagus distal 400 Test Kit
• 00813545027087: AEmA (anti-endomysial) Monkey Esophagus distal 96 Test Kit
• 00813545027070: AEmA (anti-endomysial) Monkey Esophagus distal 48 Test Kit
• 00813545027063: APCA (anti-parietal cell) Mouse Stomach 48 Test Kit
• 00813545027056: APCA (anti-parietal cell) Mouse Stomach 96 Test Kit