Product code LKT
- Device name
- Respiratory Syncytial Virus, Antigen, Antibody, Ifa
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3480
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | 2008-12-23 |
| K983336 | PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 | Diagnostic Products Corp. | 1999-03-18 |
| K943317 | PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) | Diagnostic Products Corp. | 1994-12-19 |
| K942173 | RSV ANTIGEN TEST | Neogenex | 1994-06-30 |
| K912842 | RSV-MAB TEST | Gull Laboratories, Inc. | 1991-12-09 |
| K912838 | BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO | Baxter Diagnostics, Inc. | 1991-09-27 |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | Vitek Systems, Inc. | 1991-09-23 |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | Bion Ent., Ltd. | 1989-10-16 |
| K884192 | RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | 1988-11-22 |
| K882687 | ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST | Gull Laboratories, Inc. | 1988-08-30 |
| K873564 | GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES | Genetic Systems Corp. | 1987-11-20 |
| K872701 | RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL | Sita, Inc. | 1987-09-18 |
| K872082 | RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE | Medical Diagnostic Technologies, Inc. | 1987-07-31 |
| K870176 | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT | Genetic Systems Corp. | 1987-07-16 |
| K871230 | ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K862321 | CELLMATICS RSV DETECTION SYSTEM | Difco Laboratories, Inc. | 1986-08-21 |
| K861379 | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT | Serono Diagnostics, Inc. | 1986-07-16 |
| K852472 | ABBOTT RSV EIA | Abbott Laboratories | 1985-09-17 |
| K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT | Bartels Immunodiagnostic Supplies, Inc. | 1985-08-19 |
| K844721 | INNOFLUOR PRIMIDONE | Innotron Diagnostics | 1985-01-08 |
| K842047 | ORTHO* RSV ANTIGEN ELISA TEST SYS | Ortho Diagnostic Systems, Inc. | 1984-10-05 |
| K841527 | ORTHO RESPIRATORY SYNCYTIAL VIRUS- | Ortho Diagnostic Systems, Inc. | 1984-08-12 |
| K831924 | ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS | Electro-Nucleonics Laboratories, Inc. | 1983-08-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04053252282393 | Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control Slides | EMD Millipore Corporation | 2022-12-01 |
| 04053252332555 | Light Diagnostics ™ SimulFluor® RSV/Para 3 Reagent | EMD Millipore Corporation | 2022-11-30 |
| 04053252472978 | Light Diagnostics ™ RSV FITC-Labeled Monoclonal Antibody | EMD Millipore Corporation | 2022-11-30 |
| 04053252783234 | Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control Slide | EMD Millipore Corporation | 2022-11-30 |
| 04053252589591 | Light Diagnostics ™ RSV Monoclonal Antibody | EMD Millipore Corporation | 2022-11-29 |
| 04053252732294 | Light Diagnostics™ SimulFluor® RSV/Para 3 DFA Kit | EMD Millipore Corporation | 2022-11-28 |
| 08436037124624 | Light Diagnostics™ Respiratory Syncytial Virus DFA Kit | EMD Millipore Corporation | 2022-11-28 |
| 05056080501680 | PathoDX Respiratory Viral Panel | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501796 | PathoDX RSV Control Slides | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501789 | PathoDX RSV Direct Specimen | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501772 | PathoDX RVP Control Slides | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501765 | PathoDX Respiratory Mounting Fluid | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501758 | PathoDX RSV Reagent | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501741 | PathoDx Parainfluenza 3 Reagent | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501734 | PathoDx Parainfluenza 2 Reagent | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501727 | PathoDx Parainfluenza 1 Reagent | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501710 | PathoDX Adenovirus Reagent | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501703 | PathoDX Influenza B Reagent | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501697 | PathoDX Influenza A Reagent | REMEL EUROPE LIMITED | 2021-07-21 |
| 30014613330950 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2019-04-19 |
| 30014613330868 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330844 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330851 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330875 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330776 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 30014613330820 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 30014613330837 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 30014613330769 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 30014613330813 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |
| 30014613330752 | D3 Fastpoint | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |