DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DBL
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K180202 | immuno concepts, n.a. | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immun | October 19, 2018 |
| K980312 | inova diagnostics | NOVA LITE ENDOMYSIAL | April 2, 1998 |
| K974169 | wieslab | WIELISA ANTI-GBM TEST SYSTEM | February 17, 1998 |
| K971464 | euro-diagnostica | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | October 29, 1997 |
| K971658 | jay h. geller | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | May 23, 1997 |
| K963525 | shield diagnostics | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | November 7, 1996 |
| K955431 | binding site | RIT LIVER, KIDNEY, STOMACH IFA KIT | April 23, 1996 |
| K953495 | scimedx | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | April 10, 1996 |
| K944192 | light diagnostics | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | March 6, 1995 |
| K944191 | light diagnostics | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | March 6, 1995 |
| K913360 | immco diagnostics | ANTI-RETICULIN ANTIBODY (ARA) TEST | September 26, 1994 |
| K912551 | immco diagnostics | ANTI-ENDOMYSIAL ANTIBODY TEST | June 9, 1993 |
| K904181 | biochemical diagnostic | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | September 10, 1991 |
| K902237 | medica | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | July 9, 1990 |
| K891098 | immco diagnostics | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | March 22, 1989 |
| K891099 | immco diagnostics | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | March 22, 1989 |
| K883915 | immco diagnostics | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | October 19, 1988 |
| K871194 | cronus | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT | April 20, 1987 |
| K821576 | immuno-products industries | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | June 10, 1982 |
| K820088 | calbiochem-behring | AFT SYSTEM PROFICIENCY TESTING PROGRAM | January 26, 1982 |