FDA.reportPublic FDA data

Miris Check™

Primary DI
07350107530027
Brand
Miris Check™
Company
Miris AB
Model
39-01-003
Catalog number
39-01-003
Device description
Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionized water and mix. Warm to 35-40° C before use.
Published
2019-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEIBreast Milk Macronutrients Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEIBreast Milk Macronutrients Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180007000Miris Human Milk AnalyzerMiris AB2018-12-21QEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350107530027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350107530027073501075300277350107530027

GMDN Terms#

Term, Definition table
TermDefinition
Optical instrument calibration/verification solution IVDA reference solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical instrument (e.g., spectrophotometer, nephelometer, microplate reader, real-time PCR instrument). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions of liquid-handling instruments, using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00dark
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4618146907support@mirissolutions.com

Regulatory Flags#

DUNS number
632704677
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350107530079Miris Human Milk Analyzer™Miris HMA US08-02-1072019-04-23
07350107530041Miris Calibration Control Kit™05-07-10105-07-1012022-05-04
07350107530034Miris Cleaner™39-04-001 39-04-001 2019-04-23
87350107530047Miris Calibration Control Kit™05-07-10105-07-1012022-05-04
27350107530076Miris Human Milk Analyzer™Miris HMA US08-02-1072019-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17350107530079Miris Human Milk Analyzer™Miris ABQEI2019-04-23
07350107530034Miris Cleaner™Miris ABQEI2019-04-23
27350107530076Miris Human Milk Analyzer™Miris ABQEI2019-04-23