DDZ · Albumin, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5040 · Class 2
Overview
| Product Code | DDZ |
|---|---|
| Device Name | Albumin, Fitc, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5040 |
| Device Class | Class 2 |
| Review Panel | Immunology |
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.
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 § 866.9.
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | Good Biotech Corp. | Apr 21, 2005 | SESE |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | Pointe Scientific, Inc., | Apr 28, 2003 | SESE |
| K002674 | RANDOX MICROALBUMIN | Randox Laboratories, Ltd. | Oct 5, 2000 | SESE |
| K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | Dako Corp. | Jul 18, 1983 | SESE |
Top Applicants
- Randox Laboratories, Ltd. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance
- Good Biotech Corp. — 1 clearance
- Dako Corp. — 1 clearance
