Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
FDA product code DBL · Class II (moderate risk) · 21 CFR 866.5660 · Immunology
24510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Immco Diagnostics, Inc. 5
- Light Diagnostics 2
- Biochemical Diagnostic, Inc. 1
- Immuno Concepts, N.A. , Ltd. 1
- Inova Diagnostics, Inc. 1
- Wieslab AB 1
- Euro Diagnostica AB 1
- Jay H. Geller 1
- Shield Diagnostics, Ltd. 1
- The Binding Site, Ltd. 1
- Scimedx Corp. 1
- Meda Stat Diagnostics, Inc. 1
- Medica Corp. 1
- Cronus 1
- Immuno-Products Industries 1
- Calbiochem-Behring Corp. 1
- Zeus Scientific, Inc. 1
- Immuno-Diagnostic Products, Inc. 1
- Kallestad Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsDBL · Traditional | Immuno Concepts, N.A. , Ltd. | 10/19/2018SE |
| K980312 | Nova Lite EndomysialDBL · Traditional | Inova Diagnostics, Inc. | 04/02/1998SE |
| K974169 | Wielisa Anti-Gbm Test SystemDBL · Traditional | Wieslab AB | 02/17/1998SE |
| K971464 | Immunoscan Anti-Gbm Quantitative KitDBL · Traditional | Euro-Diagnostica AB | 10/29/1997SE |
| K971658 | Mouse Liver Kidney Stomach Diagnostic Test KitDBL · Traditional | Jay H. Geller | 05/23/1997SE |
| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | Shield Diagnostics, Ltd. | 11/07/1996SE |
| K955431 | Rit Liver, Kidney, Stomach Ifa KitDBL · Traditional | The Binding Site, Ltd. | 04/23/1996SE |
| K953495 | Eia Kit for the Detection of GBM AntibodiesDBL · Traditional | Scimedx Corp. | 04/10/1996SE |
| K944192 | Anti-Nuclear Antibody (Ana) Test Kit W/Rat LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
| K944191 | Anti-Nuclear Antibody(Ana) Test Kit W/Mouse LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
| K913360 | Anti-Reticulin Antibody (Ara) TestDBL · Traditional | Immco Diagnostics, Inc. | 09/26/1994SE |
| K912551 | Anti-Endomysial Antibody TestDBL · Traditional | Immco Diagnostics, Inc. | 06/09/1993SE |
| K904181 | Anti-Gbm Antibodies Quantitative KitDBL · Traditional | Biochemical Diagnostic, Inc. | 09/10/1991SE |
| K902237 | Medica Iif Anti-Skin Antibody Test KitDBL · Traditional | Medica Corp. | 07/09/1990SE |
| K891099 | Anti-Skin Antibody Test(Monkey/Guin Pig Esoph Sec)DBL · Traditional | Immco Diagnostics, Inc. | 03/22/1989SE |
| K891098 | Anti-Skin Antibody Test(Monkey Esophagus Sections)DBL · Traditional | Immco Diagnostics, Inc. | 03/22/1989SE |
| K883915 | Autoantibody Test System (Mouse Kidney/Stomach)DBL · Traditional | Immco Diagnostics, Inc. | 10/19/1988SE |
| K871194 | I-125 Anti-Microsomal Antibody Irma Test KitDBL · Traditional | Cronus | 04/20/1987SE |
| K821576 | Antinuclear Antibody Screen FlourescDBL · Traditional | Immuno-Products Industries | 06/10/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | Calbiochem-Behring Corp. | 01/26/1982SE |
| K811261 | Anti-Skin Antibody Test SystemDBL · Traditional | Zeus Scientific, Inc. | 08/12/1981SE |
| K801960 | Anti-Ds/N-Dna Test KitDBL · Traditional | Immuno-Diagnostic Products, Inc. | 10/10/1980SE |
| K792610 | Kallestad Florescent Ana/Ama/Asma TestDBL · Traditional | Kallestad Laboratories, Inc. | 02/22/1980SE |
| K791996 | Multiple Auto Antibody TestDBL · Traditional | Meda Stat Diagnostics, Inc. | 01/16/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2430-2008 | Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney…The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128… | Bio-Rad Laboratories | 07/29/2008Terminated |