QC Kit, Level A 10793

GUDID 00386100001872

EasyQC Quality Control Kit - Level for use with EasyRA Analyzer

MEDICA CORPORATION

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 00386100001872
• NIH Device Record Key: 7947ccc4-4cbd-4aac-98a0-a95429500af7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QC Kit, Level A
• Version Model Number: 10793
• Catalog Number: 10793
• 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	00386100001872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080404

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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

Devices Manufactured by MEDICA CORPORATION

• 00386100001735 - Urine Creatinine Calibrator Kit: 2019-03-11 Urine Creatinine Calibrator Kit for use with EasyRA Analyzer
• 00386100001742 - Chemistry HDL Calibrator Kit: 2019-03-11 HDL Calibrator Kit for use with EasyRA Analyzer
• 00386100001766 - Chemistry LDL Calibrator: 2019-03-11 LDL Calibrator for use with EasyRA Analyzer
• 00386100001773 - Chemistry UALB Calibrator Kit: 2019-03-11 Microalbumin Calibrator Kit for use with EasyRA Analyzer
• 00386100001797 - Chemistry HbA1c Calibrator Kit: 2019-03-11 HbA1c Calibrator Kit for use with EasyRA Analyzer
• 00386100001803 - CRP Calibrator Kit: 2019-03-11 CRP Calibrator Kit for use with EasyRA Analyzer
• 00386100001858 - Wash1 Kit: 2019-03-11 Wash1 Kit for use with EasyRA Analyzers
• 00386100001872 - QC Kit, Level A: 2019-03-11EasyQC Quality Control Kit - Level for use with EasyRA Analyzer
• 00386100001872 - QC Kit, Level A: 2019-03-11 EasyQC Quality Control Kit - Level for use with EasyRA Analyzer