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 Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use
Primary Device ID87350107530047
NIH Device Record Keycaff1e05-641e-4221-9206-4309ce3fca13
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiris Calibration Control Kit™
Version Model Number05-07-101
Catalog Number05-07-101
Company DUNS632704677
Company NameMiris AB
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com

Device Dimensions

Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter
Total Volume8 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark

Device Identifiers

Device Issuing AgencyDevice ID
GS107350107530041 [Primary]
GS187350107530047 [Unit of Use]

FDA Product Code

OHQMulti-Analyte Controls Unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-12
Device Publish Date2022-05-04

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
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