DBJ · Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology · 21 CFR 866.5110 · Class 2
Overview
| Product Code | DBJ |
|---|---|
| Device Name | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control |
| Regulation | 21 CFR 866.5110 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12 to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12 deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930422 | SYNELISA PARIETAL CELL ANTIBODIES | Elias U.S.A., Inc. | Aug 3, 1993 | SESE |
| K790759 | IIF-APCA TEST KIT | Medica Corp. | Jul 30, 1979 | SESE |
Top Applicants
- Medica Corp. — 1 clearance
- Elias U.S.A., Inc. — 1 clearance
