DBL · Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | DBL |
|---|---|
| Device Name | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | Oct 19, 2018 | SESE |
| K980312 | NOVA LITE ENDOMYSIAL | Inova Diagnostics, Inc. | Apr 2, 1998 | SESE |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | Wieslab AB | Feb 17, 1998 | SESE |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | Euro-Diagnostica AB | Oct 29, 1997 | SESE |
| K971658 | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | Jay H. Geller | May 23, 1997 | SESE |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Shield Diagnostics, Ltd. | Nov 7, 1996 | SESE |
| K955431 | RIT LIVER, KIDNEY, STOMACH IFA KIT | The Binding Site, Ltd. | Apr 23, 1996 | SESE |
| K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | Scimedx Corp. | Apr 10, 1996 | SESE |
| K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | Light Diagnostics | Mar 6, 1995 | SESE |
| K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | Light Diagnostics | Mar 6, 1995 | SESE |
| K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | Immco Diagnostics, Inc. | Sep 26, 1994 | SESE |
| K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | Immco Diagnostics, Inc. | Jun 9, 1993 | SESE |
| K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | Biochemical Diagnostic, Inc. | Sep 10, 1991 | SESE |
| K902237 | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | Medica Corp. | Jul 9, 1990 | SESE |
| K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | Immco Diagnostics, Inc. | Mar 22, 1989 | SESE |
| K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | Immco Diagnostics, Inc. | Mar 22, 1989 | SESE |
| K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | Immco Diagnostics, Inc. | Oct 19, 1988 | SESE |
| K871194 | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT | Cronus | Apr 20, 1987 | SESE |
| K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | Immuno-Products Industries | Jun 10, 1982 | SESE |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Calbiochem-Behring Corp. | Jan 26, 1982 | SESE |
Top Applicants
- Immco Diagnostics, Inc. — 5 clearances
- Light Diagnostics — 2 clearances
- Zeus Scientific, Inc. — 1 clearance
- Wieslab AB — 1 clearance
- The Binding Site, Ltd. — 1 clearance
