Product code JSS
- Device name
- Kit, Identification, Enterobacteriaceae
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- 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 |
|---|---|---|---|
| K150031 | hemoFISH Masterpanel | Miacom Diagnostics GmbH | 2015-10-01 |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | Advandx, Inc. | 2013-07-21 |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | Advandx, Inc. | 2010-12-16 |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-12-16 |
| K092393 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-09-01 |
| K082068 | E. COLI PNA FISH | Advandx, Inc. | 2009-06-25 |
| K081433 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-03-26 |
| K081309 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2008-12-19 |
| K926002 | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL | Alamar Biosciences Laboratory, Inc. | 1993-09-23 |
| K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 |
| K926017 | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 |
| K924814 | API 20E/UNISCEPT 20E | Analytical Products, Inc. | 1993-03-11 |
| K922588 | ROCHE ENTEROTUBE II | Roche Diagnostic Systems, Inc. | 1992-09-11 |
| K912924 | RAMBACH AGAR | Rantran, Inc. | 1992-02-28 |
| K894776 | SENSITITRE INDOLE REAGENT | Radiometer America, Inc. | 1989-08-31 |
| K890626 | RAPIDEC COLI | Dms Products, Inc. | 1989-06-02 |
| K883558 | VITEK GRAM-NEGATIVE IDENTIFICATION CARD | Vitek Systems, Inc. | 1988-09-16 |
| K863603 | GI MOTILITY TEST MEDIUM W/TTC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 |
| K861774 | QUADRA-TITER (TM) I.D. (MODIFICATION) | Microtech Medical Systems, Inc. | 1986-05-20 |
| K854733 | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) | Dms Products, Inc. | 1986-03-06 |
| K853009 | COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT | Roche Diagnostic Systems, Inc. | 1986-03-04 |
| K860208 | QUADRA-TITER I.D. | Microtech Medical Systems, Inc. | 1986-03-03 |
| K852871 | IDS RAPID SS/U SYSTEM | Innovative Diagnostic Systems, Inc. | 1985-07-23 |
| K852110 | IDS RAPID E PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | 1985-06-04 |
| K851978 | LYFO-KWIK OMI KIT | Micro-Bio-Logics | 1985-06-04 |
| K843571 | RIM-UREA | Austin Biological Laboratories | 1984-10-01 |
| K834090 | TITERTEK ENTEROBAC* | Flow Laboratories, Inc. | 1984-01-13 |
| K833612 | FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI | Petra Biomedical Products, Inc. | 1983-12-12 |
| K833613 | FLUOR-B MEL A DIRECT FLUORESCENT ANTI | Petra Biomedical Products, Inc. | 1983-12-12 |
| K831672 | SPECTRUM-10 | Austin Biological Laboratories | 1983-06-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848838023040 | REMEL | REMEL, INC. | 2023-01-03 |
| 00848838058110 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838058193 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838058117 | Remel | REMEL, INC. | 2021-11-12 |
| 30848838058197 | Remel | REMEL, INC. | 2021-11-12 |
| 30848838058111 | Remel | REMEL, INC. | 2021-11-12 |
| 00848838058196 | Remel | REMEL, INC. | 2021-11-12 |
| 03573026588526 | RAPID 20 E™ | BIOMERIEUX SA | 2020-04-10 |
| 03573026588649 | RAPID ID 32 E | BIOMERIEUX SA | 2020-04-10 |
| 03573026588489 | API® 20 E | BIOMERIEUX SA | 2020-04-10 |
| 03573026588410 | API® 20 E Reagent QC | BIOMERIEUX SA | 2020-04-10 |
| 03573026047702 | API® 20 NE | BIOMERIEUX SA | 2020-04-10 |
| 03573026048136 | API® 20 E Reagent QC | BIOMERIEUX SA | 2020-04-10 |
| 03573026048013 | API 20 E™ | BIOMERIEUX SA | 2020-04-10 |
| 03573026048617 | RAPID 20 E™ | BIOMERIEUX SA | 2020-04-10 |
| 03573026066574 | rapid ID 32 E | BIOMERIEUX SA | 2020-04-10 |
| 03573026092443 | ID indole TDA | BIOMERIEUX SA | 2019-07-19 |