Identity
- Trade Name
- Miris Calibration Control Kit™ FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 05-07-101 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 05-07-101 FDA UDI
- Primary DI / UDI-DI
- 07350107530041 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 8 Milliliter FDA UDI
Category: Optical laboratory instrument performance standard calibrator/control IVD, single-use
Miris Calibration Control Kit™ by Miris AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Miris AB
Sources (1)
- FDA UDI caff1e05-641e-4221-9206-4309ce3fca13 37 fields · synced May 30, 2026