| 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 |
| M Type Endoscope Coupler (1 supplier) | |
| M-2 Razor Blades (1 supplier) | |
| M9 Broth (1 supplier) | |
| Macintosh Type Curved Laryngoscope Blade (3 suppliers) | |
| Macintosh Type Straight Laryngoscope Blades (2 suppliers) | |
| Macro Balance (6 suppliers) | |
| Macro Pipette (35 suppliers) | |
| Macro Plates (1 supplier) | |
| Macrodermabrasion Devices (4 suppliers) | |
| Macrophage Markers (1 supplier) | |
| Macular Adaptometers (1 supplier) | |
| Macular Degeneration Testings (1 supplier) | |
| Maddox Rods (1 supplier)
The Maddox rod is a device used in the diagnosis of extraocular muscle imbalance. It consists of a series of powerful convex cylindrical lenses mounted side by side in a trial lens. The patient views a distant white point source of light through the Maddox rod, which is placed close to the eye. It consists of a row of such cylinders, and thus a row of foci are formed on the retina. These foci join up and are seen as a line of light, which lies at 90° to the axis of the Maddox rod.
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| Magill Catheter Forceps (3 suppliers) | |
| Magill Forceps (6 suppliers) | |
| Magnascope (1 supplier) | |
| Magnehelic Gauges (1 supplier) | |
| Magnesium (5 suppliers)
Magnesium is an essential mineral for human nutrition. Magnesium in the body serves several important metabolic functions. It plays a role in the production and transport of energy. It is also important for the contraction and relaxation of muscles. It is involved in the synthesis of protein, and assists in the functioning of certain enzymes in the body.
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| Magnesium Sulfate Injection (1 supplier) | |
| Magnesium Tuning Forks (17 suppliers) | |
| Magnetic Back Support Belts (1 supplier) | |
| Magnetic Coronary Guidewires (2 suppliers) | |
| Magnetic Dialysate Conductivity Sensors (1 supplier) | |
| Magnetic Drapes (1 supplier) | |
| Magnetic Extended Shoulder Brace (1 supplier) | |
| Magnetic Field Shield (6 suppliers) | |
| Magnetic Heating Stirrer (2 suppliers) | |
| Magnetic Immobilization Kits (1 supplier) | |
| Magnetic Inner Liner (1 supplier) | |
| Magnetic Instrument Drape (1 supplier) | |
| Magnetic Instrument Pads (1 supplier) | |
| Magnetic Knee Support (38 suppliers) | |
| Magnetic Metal Detector (2 suppliers) | |
| Magnetic Metal Extractor (1 supplier) | |
| Magnetic Needle Counters (5 suppliers) | |
| Magnetic Pedal Exercisers (2 suppliers) | |
| Magnetic PEEP Valve Port (1 supplier) | |
| Magnetic PEEP Valve Replacement Port (1 supplier) |
