21 CFR 862.1440 — 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1440
Identification
A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CER | 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase | 2 | 1 | |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 2 | 13 | |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 111 |
Special Controls
CER — 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
eCFR
CFH — Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
eCFR
CFJ — Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
eCFR
