JTO · Discs, Strips And Reagents, Microorganism Differentiation
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JTO |
|---|---|
| Device Name | Discs, Strips And Reagents, Microorganism Differentiation |
| 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 244)
Showing 20 most recent of 244 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050352 | IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT | Ameritek Research, LLC | Sep 1, 2005 | SESE |
| K970832 | PYR SWAB | Remel, Inc. | Apr 24, 1997 | SESE |
| K970834 | GRAM SWAB | Remel, Inc. | Apr 17, 1997 | SESE |
| K970833 | INDOLE SWAB | Remel, Inc. | Apr 2, 1997 | SESE |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | Microbiologics, Inc. | Feb 6, 1997 | SESE |
| K962966 | IDS RAPID CB PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | Oct 8, 1996 | SESE |
| K961191 | COLISCREEN | Hardy Diagnostics | Jun 17, 1996 | SESE |
| K960996 | M. CAT BUTYRATE DISK | Hardy Diagnostics | Apr 18, 1996 | SESE |
| K955826 | GIBSON ID-M. CAT. | Gibson Laboratories, Inc. | Feb 29, 1996 | SESE |
| K954783 | DRYSLIDE CARTARRHALIS | Difco Laboratories, Inc. | Feb 6, 1996 | SESE |
| K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR | Microbiologics, Inc. | Dec 20, 1995 | SESE |
| K953247 | GIBSON ID A.E. TEST | Gibson Laboratories, Inc. | Nov 20, 1995 | SESE |
| K951889 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | Aug 24, 1995 | SESE |
| K950346 | B-L RED(TM) DISCS | Oxis Intl., Inc. | May 5, 1995 | SESE |
| K945883 | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN | Microbiologics, Inc. | Apr 24, 1995 | SESE |
| K945882 | LYFO(TM) DIFFERENTIAL DISK-BILE | Microbiologics, Inc. | Apr 24, 1995 | SESE |
| K945881 | LYFO(TM) DIFFERENTIAL DISK-STERILE DISK | Microbiologics, Inc. | Apr 24, 1995 | SESE |
| K945880 | LYFO(TM) DIFFERENTIAL DISK-SPS | Microbiologics, Inc. | Apr 24, 1995 | SESE |
| K934130 | SWABZYME OXIDASE | E-Y Laboratories, Inc. | Sep 14, 1994 | SESE |
| K940162 | GONOCHEK II REAGENT TUBES | E-Y Laboratories, Inc. | Sep 9, 1994 | SESE |
Top Applicants
- Remel Co. — 46 clearances
- Difco Laboratories, Inc. — 34 clearances
- Dms Laboratories — 13 clearances
- Austin Biological Laboratories — 12 clearances
- E-Y Laboratories, Inc. — 11 clearances
