| PRODUCT NAME | FDA Code/Regulation |
| Mycophenolic Acid Test System (4 suppliers) Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus. Classification. Class II (special controls). The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Sirolimus Test Systems." See 862.1(d) for the availability of this guidance document. | OAV / 862.3840 |
| Mycoplasma Detection Kit (4 suppliers) Identification. Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures. Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. | KIW / 864.2360 |
| Mycoplasma Detection Media (3 suppliers) Identification. Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures. Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. | KIX / 864.2360 |
| Mycoplasma Spp Antiserum (5 suppliers) | GSA / 866.3375 |
| Mycoplasma Spp CF Antigen (6 suppliers) | GSB / 866.3375 |
| Mycoplasma Spp Enzyme Linked Immunoabsorbent Assay (15 suppliers) | LJZ / 866.3375 |
| Mycoplasma Spp. DNA-Reagents (7 suppliers) | LQG / 866.3375 |
| Mycoplasma Spp. Fluorescent Antisera (3 suppliers) | GRZ / 866.3375 |
| Myoglobin (37 suppliers)
Myoglobin is a protein in heart and skeletal muscles. When a muscle is exercised, it uses up available oxygen. It has oxygen bound to it, thus providing an extra reserve of oxygen so that the muscle can maintain a high level of activity for a longer period of time. Serum myoglobin is a test that measures the amount of myoglobin in the blood. The levels may be obtained to confirm suspected muscle damage, including heart and skeletal muscle damage.
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. Classification. Class II (performance standards). | DDR / 866.5680 |
| Myoglobin Immunoassay Biosensor (2 suppliers) Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. Classification. Class II (performance standards). | MVE / 866.5680 |
| Myringotomy Knife (33 suppliers) | JYP / 874.4420 |
| Myringotomy Tube Inserter (15 suppliers) | JYM / 874.4420 |
| Myringotomy Tube (3 suppliers) | |
| Metaphase Cell Locators (1 supplier) | |
| Middle Ear Spatula (4 suppliers) | |
| Middle Ear Surgery Drill (2 suppliers) | |
| Middle Ear Mirror (1 supplier) | |
| Middle Ear Balloon (1 supplier) | |
| Measuring Passive Exerciser (2 suppliers) | |
| Microtome Blade Sharpener (3 suppliers) | |
| Micro Bone Cutting Saw (4 suppliers) | |
| Mobile Powered Traction Unit (3 suppliers) | |
| Maxillofacial Prosthesis (6 suppliers) | |
| Moist Heat Compress (4 suppliers) | |
| Magnetic Field Shield (6 suppliers) | |
| Magnetic Resonance Imaging Gas Mixtures (1 supplier) | |
| Mobile C-Arm Radiographic/Fluoroscopic Unit (12 suppliers) | |
| Mobile Radiographic Unit Battery (4 suppliers) | |
| Motorized Radiographic Film Viewer (5 suppliers) | |
| Manual Radiographic Film Processor (2 suppliers) | |
| Mammographic Phantom (3 suppliers) | |
| Moist Therapy Pack (7 suppliers) | |
| Moist Therapy Pack Conditioner (1 supplier) | |
| Muscle Electrical Stimulator (7 suppliers) | |
| Mechanical Wheeled Stretcher (12 suppliers) | |
| Metallic Surface Biopotential Electrode (2 suppliers) | |
| Metallic with Soft Pad Covering Electrode (2 suppliers) | |
| Mechanical Goniometer (4 suppliers) | |
| MRI Permanent Magnet (5 suppliers) | |
| MRI Superconducting Magnet (4 suppliers) | |
| Multi-Image Camera (6 suppliers) | |
| Multipurpose Lithotriptor (3 suppliers) | |
| Mushroom Catheter (1 supplier) | |
| Miller-Abbott Gastrointestinal Decompression Tube (1 supplier) | |
| Mini-Diameter Choledochoscope (1 supplier) | |
| Medical Radiographic Personal Monitoring Device (2 suppliers) | |
| Mobile Stand Snake Hose Examination Lamp (0 suppliers) | |
| Micro Tubes with Caps (1 supplier) | |
| Micro Tubes with Soft Cap (1 supplier) | |
| Macro Plates (1 supplier) |
