Scanlisa C1q Elisa 96 Test C1196

GUDID 00813545023737

SCIMEDX CORPORATION

Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA) Complement component C1q IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00813545023737
• NIH Device Record Key: ad102e43-68bc-4a08-8765-3d51a87f2652
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanlisa C1q Elisa 96 Test
• Version Model Number: C1196
• Catalog Number: C1196
• 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
• 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	00813545023737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833636

FDA Product Code

• DAK: Complement C1q, Antigen, Antiserum, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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