Panels › Immunology › Product code KTL · Class 2
Anti-Dna Indirect Immunofluorescent Solid Phase
Regulation 866.5100
0510(k)s in 12 months (19 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KTL
| Company | 510(k)s | Recalls |
|---|---|---|
| Euroimmun Us, Inc. | 2 | 0 |
| Intl. Diagnostic Technology | 2 | 0 |
| Amersham Corp. | 1 | 0 |
| Apple Diagnostic Products | 1 | 0 |
| The Binding Site, Ltd. | 1 | 0 |
| Breit Laboratories, Inc. | 1 | 0 |
| Cappel Diagnostics, Inc. | 1 | 0 |
| Immuno Concepts, Inc. | 1 | 0 |
| Immuno Concepts, N.A. , Ltd. | 1 | 0 |
| Immuno-Products Industries | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2023 | K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine Zeus Scientific | KTL |
| May 26, 2023 | K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System Immuno Concepts, N.A. , Ltd. | KTL |
| Dec 11, 2020 | K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit Inova Diagnostics, Inc. | KTL |
| Apr 20, 2018 | K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern Euroimmun Us, Inc. | KTL |
| Apr 20, 2018 | K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern Euroimmun Us, Inc. | KTL |
| Apr 11, 2002 | K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L Rhigene, Inc. | KTL |
| Nov 29, 2001 | K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G Immuno Concepts, Inc. | KTL |
| Apr 21, 1999 | K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY Stellar Bio Systems, Inc. | KTL |
| Aug 10, 1993 | K930987 | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) The Binding Site, Ltd. | KTL |
| Dec 13, 1990 | K905386 | DISTAT ANTI-DSDNA KIT Shield Diagnostics, Ltd., GB | KTL |
| Dec 15, 1986 | K864275 | ANTI-NDNA ANTIBODY TEST KIT Cappel Diagnostics, Inc. | KTL |
| Jun 10, 1986 | K861978 | AUTOFLUOR V Technia Diagnostics , Ltd. | KTL |
| Aug 21, 1984 | K842707 | ADP NDNA IFA TEST Apple Diagnostic Products | KTL |
| Apr 19, 1984 | K834349 | ANTI-NATIVE DNA ANTIBODY Sigma Chemical Co. | KTL |
| Jan 20, 1984 | K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS Intl. Diagnostic Technology | KTL |
| Jan 4, 1984 | K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL Intl. Diagnostic Technology | KTL |
| Aug 11, 1983 | K832031 | ANTI-N DNA ANTIBODY TEST KIT Breit Laboratories, Inc. | KTL |
| Mar 24, 1983 | K830652 | ANTI N DNA-HCP Immuno-Products Industries | KTL |
| Sep 17, 1979 | K791354 | CODE QAS 103 ANTI-DNA CONTROLS Amersham Corp. | KTL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.