Diamedix

GUDID 00817273020112

"720-280 anti-Scl-70 Test Kit"

DIAMEDIX CORPORATION

Scleroderma-70 antibody (anti-Scl-70) IVD, reagent

• Primary Device ID: 00817273020112
• NIH Device Record Key: 110ccd6f-c06b-4cc9-9b54-71e0f275bb96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamedix
• Version Model Number: 720-280
• Company DUNS: 151765328
• Company Name: DIAMEDIX 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 305-324-2300
• Email: Customerservice@erbadiagnostics.com
• Phone: 305-324-2300
• Email: Customerservice@erbadiagnostics.com
• Phone: 305-324-2300
• Email: Customerservice@erbadiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817273020112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970239

FDA Product Code

• LLL: Extractable Antinuclear Antibody, Antigen And 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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