Miris Calibration Control Kit™
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…
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.
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
Record
| Listed by | Miris AB, Sweden |
|---|---|
| FDA product code | OHQ |
| Device type | Multi-Analyte Controls Unassayed |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-04 |
| Record revised | 2023-10-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Storage | Storage environment temperature 20 to 30 °C; Special storage condition: dark |
| Sizes | Total volume 8 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 05-07-101 | Total Volume 8 ml | 10 | In distribution |
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| Helix Elite™ Molecular Standards: Inactivated Standard | Microbiologics, Inc. | 41 |
| Multichem S Plus | Techno-Path Manufacturing Ltd. | 35 |
| Virotrol | Bio-Rad Laboratories Inc. | 27 |
| Helix Elite™ Molecular Standards: Synthetic Standard | Microbiologics, Inc. | 25 |
| Multichem IA Plus | Techno-Path Manufacturing Ltd. | 17 |
| D3 | Diagnostic Hybrids, Inc. | 14 |
| Liquichek | Bio-Rad Laboratories Inc. | 10 |
| Multichem IA | Techno-Path Manufacturing Ltd. | 8 |
| QC Sets and Panels: Kwik-Stik™ 2 Pack | Microbiologics, Inc. | 8 |
Showing 12 of 107. All products under Multi-Analyte Controls Unassayed
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.