| PRODUCT NAME | FDA Code/Regulation |
| 5'-Nucleotidase 5-AMP-Phosphate Release (Colorimetric Test) (5 suppliers) Identification. A 5'-nucleotidase test system is a device intended to measure the activity of the enzyme 5'-nucleotidase in serum and plasma. Measurements of 5'-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity. Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9. | CED / 862.1520 |
| 5-Anhydroglucitol (15ag) 1 Assay (1 supplier) Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. Classification. Class II (performance standards). | NOZ / 864.7470 |
| 5-Drawer Treatment Cart (3 suppliers) | |
| 5-Fluorouracil Toxicity Tests (1 supplier) | |
| 5-Lead ECG Leadwire (2 suppliers) | |
| 5-Lead ECG Trunk Cable (5 suppliers) | |
| 5-Panel Multi-Drug Rapid Home Kit (2 suppliers) | |
| 50 mm Securing Post (1 supplier) | |
| 500 ml Soap System (1 supplier) | |
| 50cc-60cc Syringes (2 suppliers) | |
| 5Cc Two-way Foley Catheters (7 suppliers) | |
| 5cc-6cc Syringes (1 supplier) | |
| 5 Lead Safety Cable (1 supplier) |