MeDiCa 0101

GUDID 00813545026561

Rat Liver 4 Well Slide (each)

SCIMEDX CORPORATION

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: 00813545026561
• NIH Device Record Key: 114f4ff5-d69b-424a-b0cf-8a428d98fc62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeDiCa
• Version Model Number: 0101
• Catalog Number: 0101
• 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	00813545026561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K782048

FDA Product Code

• DHN: Antinuclear 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