Miris Calibration Control Kit™ 05-07-101

GUDID 87350107530047

Quality control material for the Miris Human Milk Analyzer™. Miris Calibration Control Kit™ includes standardised solutions in two concentrations, Miris Calibration Control 1 and Miris Calibration Control 2. One package contains 20 vials, 10 vials of each solution. One vial of each solution constitute one kit. 8 ml liquid volume per vial. Warm the solutions to 35-40°C and homogenize the vial content, according to the method indicated in the instructions for use, before use.

Miris AB

Optical instrument performance standard calibrator/control IVD, single-use

• Primary Device ID: 87350107530047
• NIH Device Record Key: caff1e05-641e-4221-9206-4309ce3fca13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miris Calibration Control Kit™
• Version Model Number: 05-07-101
• Catalog Number: 05-07-101
• Company DUNS: 632704677
• Company Name: Miris AB
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com

Device Dimensions

• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350107530041 [Primary]
GS1	87350107530047 [Unit of Use]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

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: 2022-05-12
• Device Publish Date: 2022-05-04

Devices Manufactured by Miris AB

• 87350107530047 - Miris Calibration Control Kit™: 2022-05-12Quality control material for the Miris Human Milk Analyzer™. Miris Calibration Control Kit™ includes standardised solutions in two concentrations, Miris Calibration Control 1 and Miris Calibration Control 2. One package contains 20 vials, 10 vials of each solution. One vial of each solution constitute one kit. 8 ml liquid volume per vial. Warm the solutions to 35-40°C and homogenize the vial content, according to the method indicated in the instructions for use, before use.
• 87350107530047 - Miris Calibration Control Kit™: 2022-05-12 Quality control material for the Miris Human Milk Analyzer™. Miris Calibration Control Kit™ includes standardised solutions
• 07350107530027 - Miris Check™: 2020-06-23 Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionize
• 07350107530034 - Miris Cleaner™: 2020-06-23 Cleaning agent for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water
• 27350107530076 - Miris Human Milk Analyzer™: 2019-05-01 The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. T