Miris Calibration Control Kit™

Primary DI
87350107530047
Brand
Miris Calibration Control Kit™
Company
Miris AB
Model
05-07-101
Catalog number
05-07-101
Device description
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.
Published
2022-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350107530041PrimaryGS10
87350107530047Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350107530041073501075300417350107530041
8735010753004787350107530047

GMDN Terms#

Term, Definition table
TermDefinition
Optical 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 instrument (e.g., spectrophotometer, nephelometer, microplate reader, 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 Volume8Milliliter

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
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
17350107530079Miris Human Milk Analyzer™Miris HMA US08-02-1072019-04-23
07350107530041Miris Calibration Control Kit™05-07-10105-07-1012022-05-04
07350107530027Miris Check™39-01-003 39-01-003 2019-04-23
07350107530034Miris Cleaner™39-04-001 39-04-001 2019-04-23
27350107530076Miris Human Milk Analyzer™Miris HMA US08-02-1072019-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01220000260597NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
01220000260603NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
01220000260610NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
05391523442800Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442817Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442824Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
00850051429905Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429912Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429929Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
05056850400052Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
05056850400069Mimix™ Geni™ Negative FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
01220000260641NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2026-03-25
70845357044432QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2026-02-10
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
01220000260450NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
01220000260467NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Diseases ControlsFUJIREBIO INC.OHQ2025-07-31
08718734962946CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962953CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962960CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25