JSS · Kit, Identification, Enterobacteriaceae
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JSS |
|---|---|
| Device Name | Kit, Identification, Enterobacteriaceae |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (20 of 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150031 | hemoFISH Masterpanel | Miacom Diagnostics GmbH | Oct 1, 2015 | SESE |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | Advandx, Inc. | Jul 21, 2013 | SESE |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | Advandx, Inc. | Dec 16, 2010 | SESE |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | Dec 16, 2009 | SESE |
| K092393 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | Sep 1, 2009 | SESE |
| K082068 | E. COLI PNA FISH | Advandx, Inc. | Jun 25, 2009 | SESE |
| K081433 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | Mar 26, 2009 | SESE |
| K081309 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | Dec 19, 2008 | SESE |
| K926002 | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL | Alamar Biosciences Laboratory, Inc. | Sep 23, 1993 | SESE |
| K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM | Becton Dickinson Microbiology Systems | Mar 11, 1993 | SESE |
| K926017 | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM | Becton Dickinson Microbiology Systems | Mar 11, 1993 | SESE |
| K924814 | API 20E/UNISCEPT 20E | Analytical Products, Inc. | Mar 11, 1993 | SESE |
| K922588 | ROCHE ENTEROTUBE II | Roche Diagnostic Systems, Inc. | Sep 11, 1992 | SESE |
| K912924 | RAMBACH AGAR | Rantran, Inc. | Feb 28, 1992 | SESE |
| K894776 | SENSITITRE INDOLE REAGENT | Radiometer America, Inc. | Aug 31, 1989 | SESE |
| K890626 | RAPIDEC COLI | Dms Products, Inc. | Jun 2, 1989 | SESE |
| K883558 | VITEK GRAM-NEGATIVE IDENTIFICATION CARD | Vitek Systems, Inc. | Sep 16, 1988 | SESE |
| K863603 | GI MOTILITY TEST MEDIUM W/TTC | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 30, 1986 | SESE |
| K861774 | QUADRA-TITER (TM) I.D. (MODIFICATION) | Microtech Medical Systems, Inc. | May 20, 1986 | SESE |
| K854733 | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) | Dms Products, Inc. | Mar 6, 1986 | SESE |
Top Applicants
- Advandx, Inc. — 7 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- Vitek Systems, Inc. — 3 clearances
- Abbott Laboratories — 2 clearances
- Austin Biological Laboratories — 2 clearances
