21 CFR 862.1810 — Radioassay, Vitamin B12
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1810
Identification
A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | 2 | 78 | 3rd Party |
| LIG | Radioassay, Intrinsic Factor Blocking Antibody | 2 | 8 | 3rd Party |
