CZJ · Igd, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | CZJ |
|---|---|
| Device Name | Igd, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS | The Binding Site | Dec 28, 2009 | SESE |
| K051299 | IGD DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | Nov 23, 2005 | SESE |
| K002561 | SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | Oct 26, 2000 | SESE |
| K913671 | HUMAN IGD IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | Dec 2, 1991 | SESE |
| K883001 | QM300 CALIBRATOR D PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Sep 22, 1988 | SESE |
| K872834 | TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 | Helena Laboratories | Aug 12, 1987 | SESE |
| K831956 | DETERM. SIZE 72 RADIAL-HUMAN IGD | Kent Laboratories, Inc. | Jul 18, 1983 | SESE |
| K772327 | LAS-R HUMAN IGD TEST | Hyland Therapeutic Div., Travenol Laboratories | Feb 28, 1978 | SESE |
Top Applicants
- The Binding Site, Ltd. — 3 clearances
- The Binding Site — 1 clearance
- Kent Laboratories, Inc. — 1 clearance
- Kallestad Diag, A Div. of Erbamont, Inc. — 1 clearance
- Hyland Therapeutic Div., Travenol Laboratories — 1 clearance
