Product code DBL
- Device name
- Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5660
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | 2018-10-19 |
| K980312 | NOVA LITE ENDOMYSIAL | Inova Diagnostics, Inc. | 1998-04-02 |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | Wieslab AB | 1998-02-17 |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | Euro-Diagnostica AB | 1997-10-29 |
| K971658 | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | Jay H. Geller | 1997-05-23 |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Shield Diagnostics, Ltd. | 1996-11-07 |
| K955431 | RIT LIVER, KIDNEY, STOMACH IFA KIT | The Binding Site, Ltd. | 1996-04-23 |
| K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | Scimedx Corp. | 1996-04-10 |
| K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | Light Diagnostics | 1995-03-06 |
| K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | Light Diagnostics | 1995-03-06 |
| K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | Immco Diagnostics, Inc. | 1994-09-26 |
| K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-06-09 |
| K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | Biochemical Diagnostic, Inc. | 1991-09-10 |
| K902237 | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | Medica Corp. | 1990-07-09 |
| K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | Immco Diagnostics, Inc. | 1989-03-22 |
| K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | Immco Diagnostics, Inc. | 1989-03-22 |
| K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | Immco Diagnostics, Inc. | 1988-10-19 |
| K871194 | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT | Cronus | 1987-04-20 |
| K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | Immuno-Products Industries | 1982-06-10 |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Calbiochem-Behring Corp. | 1982-01-26 |
| K811261 | ANTI-SKIN ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1981-08-12 |
| K801960 | ANTI-DS/N-DNA TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-10 |
| K792610 | KALLESTAD FLORESCENT ANA/AMA/ASMA TEST | Kallestad Laboratories, Inc. | 1980-02-22 |
| K791996 | MULTIPLE AUTO ANTIBODY TEST | Meda Stat Diagnostics, Inc. | 1980-01-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00813545029029 | GBM IgG Test System | SCIMEDX CORPORATION | 2023-06-13 |
| 00813545026820 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545027292 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545027285 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545027278 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545027261 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545027223 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545027131 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545027124 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026899 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026882 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026875 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026868 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026851 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026844 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026837 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026813 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026806 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026790 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026783 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026776 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026691 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026684 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00845714004179 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714004162 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002182 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714003943 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714003479 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 08426950545798 | NOVA Lite®Rat Liver , Kidney, Stomach Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950514176 | NOVA Lite®Rat Liver , Kidney, Stomach Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |