Chemistry HbA1c Calibrator Kit 10658

GUDID 00386100001797

HbA1c Calibrator Kit for use with EasyRA Analyzer

MEDICA CORPORATION

Glycated haemoglobin (HbA1c) IVD, calibrator

• Primary Device ID: 00386100001797
• NIH Device Record Key: 28e0eb28-aaba-4005-b118-930b7b2029e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chemistry HbA1c Calibrator Kit
• Version Model Number: 10658
• Catalog Number: 10658
• Company DUNS: 112942404
• Company Name: MEDICA 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-275-4892
• Email: technicalsupport@medicacorp.com
• Phone: 781-275-4892
• Email: technicalsupport@medicacorp.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386100001797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120497

FDA Product Code

• JIT: Calibrator, Secondary

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: 2019-03-11
• Device Publish Date: 2019-02-14

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