DDB · Ceruloplasmin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5210 · Class 2
Overview
| Product Code | DDB |
|---|---|
| Device Name | Ceruloplasmin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5210 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
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 the limitations in § 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 the limitations in § 866.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161508 | Ceruloplasmin | Beckman Coulter Ireland, Inc. | Jan 9, 2017 | SESE |
| K122965 | HUMAN CAERULOPLASMIN KIT | The Binding Site Group , Ltd. | Jun 3, 2013 | SESE |
| K053074 | N ANTISERA TO HUMAN CERULOPLASMIN | Dade Behring, Inc. | Mar 16, 2006 | SESE |
| K964762 | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | Beckman Instruments, Inc. | Apr 25, 1997 | SESE |
| K913668 | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | Dec 20, 1991 | SESE |
| K895377 | QM300 CERULOPLASMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Sep 21, 1989 | SESE |
| K860138 | NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM | Sigma Diagnostics, Inc. | Mar 28, 1986 | SESE |
| K850682 | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL | Kent Laboratories, Inc. | Nov 25, 1985 | SESE |
| K852247 | LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) | Behring Diagnostics, Inc. | Jul 10, 1985 | SESE |
| K851283 | RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN | Cooper Biomedical, Inc. | May 23, 1985 | SESE |
| K823107 | QUANTIMETRIC 2 CERULOPLASMIN ASSAY | Kallestad Laboratories, Inc. | Nov 16, 1982 | SESE |
| K812486 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL | Dako Corp. | Sep 23, 1981 | SESE |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | J.T. Baker Chemical Co. | Sep 16, 1980 | SESE |
| K791339 | HUMAN CERULOPLASMIN | Beckman Instruments, Inc. | Aug 16, 1979 | SESE |
| K790714 | ANTISERUM TO HUMAN CERULOPLASMIN | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |
| K790712 | ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |
| K781024 | CERUOPLASMIN SERUM ANTI-HUMAN | Icl Scientific | Aug 14, 1978 | SESE |
| K772255 | CERULOPLASMIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | Jan 5, 1978 | SESE |
| K771795 | LAS-R CERULOPLASMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | Nov 14, 1977 | SESE |
Top Applicants
- Kent Laboratories, Inc. — 3 clearances
- Kallestad Laboratories, Inc. — 2 clearances
- Beckman Instruments, Inc. — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- The Binding Site Group , Ltd. — 1 clearance
