FDA UDI
In Commercial Distribution
🇺🇸 United States
Miris Calibration Control Kit™
DI: 07350107530041
·
Model: 05-07-101
·
Miris AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Miris Calibration Control Kit™
- Primary DI
- 07350107530041
- Version / Model
- 05-07-101
- Catalog Number
- 05-07-101
- Company Name
- Miris AB
- Labeler DUNS
- 632704677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-05-04
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- caff1e05-641e-4221-9206-4309ce3fca13
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58048 | Optical laboratory instrument performance standard calibrator/control IVD, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 87350107530047 | GS1 | ||||
| Primary | 07350107530041 | GS1 |
Customer Contacts
- Phone
- +4618146907
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 8 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- dark