KTS · Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | KTS |
|---|---|
| Device Name | Second Antibody (Species Specific Anti-Animal Gamma Globulin) |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K813508 | SAC-CEL | Burroughs Wellcome Co. | Dec 29, 1981 | SESE |
| K792637 | CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) | Union Carbide Corp. | Jan 11, 1980 | SESE |
| K792636 | CENTRIA RADIOIMMUNOASSAY SEPARATION | Union Carbide Corp. | Jan 11, 1980 | SESE |
| K781070 | SECOND ANTIBODY | Pcl-Ria, Inc. | Aug 10, 1978 | SESE |
Top Applicants
- Union Carbide Corp. — 2 clearances
- Pcl-Ria, Inc. — 1 clearance
- Burroughs Wellcome Co. — 1 clearance
