LQL · Gram Positive Identification Panel
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | LQL |
|---|---|
| Device Name | Gram Positive Identification Panel |
| 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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | Accumed Intl., Inc. | Jan 22, 1998 | SESE |
| K961968 | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 4, 1997 | SESE |
| K961730 | RAPID GRAM-POSITIVE ID SYSTEM | Becton Dickinson Microbiology Systems | Feb 4, 1997 | SESE |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Biomerieux Vitek, Inc. | Mar 12, 1996 | SESE |
| K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | Biomerieux Vitek, Inc. | Mar 23, 1993 | SESE |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Vitek Systems, Inc. | Jul 26, 1991 | SESE |
| K910537 | VISI-STREP | Kev Connecticut Diagnostics, Inc. | Apr 12, 1991 | SESE |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Analytical Products, Inc. | Sep 10, 1990 | SESE |
| K891004 | RAPIDEC STAPH | Dms Products, Inc. | Nov 9, 1989 | SESE |
| K874606 | CATHRA GRAM POSITIVE SCREEN | Mct Medical, Inc. | May 6, 1988 | SESE |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | Sep 30, 1986 | SESE |
Top Applicants
- Biomerieux Vitek, Inc. — 2 clearances
- Accumed Intl., Inc. — 1 clearance
- American Micro Scan — 1 clearance
- Analytical Products, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
