ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
Device Facts
| Record ID | K780913 |
|---|---|
| Device Name | ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM |
| Applicant | Beckman Instruments, Inc. |
| Product Code | DCF · Immunology |
| Decision Date | Jun 22, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5040 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Special Controls
*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 § 866.9.
