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
Rx
false
OTC
false
Sterile
false
Single use
false

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
K223085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180007000Miris Human Milk AnalyzerMiris AB2018-12-21QEI
K223085000Miris Human Milk Analyzer (HMA)Miris AB2023-09-29QEI

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 laboratory instrument performance standard calibrator/control IVD, single-useA reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). 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 using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00dark
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
632704677
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350107530034Miris Cleaner™39-04-00139-04-0012019-04-23
17350107530079Miris Human Milk Analyzer™Miris HMA US08-02-1072019-04-23
07350107530041Miris Calibration Control Kit™05-07-10105-07-1012022-05-04
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