LQM · Gram Negative Identification Panel
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | LQM |
|---|---|
| Device Name | Gram Negative 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923313 | ROCHE OXI/FERM II | Roche Diagnostic Systems, Inc. | Apr 5, 1993 | SESE |
| K925915 | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | Biomerieux Vitek, Inc. | Mar 23, 1993 | SESE |
| K912897 | SCEPTOR IDENTIFICATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 28, 1991 | SESE |
| K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | Vitek Systems, Inc. | Jun 24, 1991 | SESE |
| K890057 | SENSITITRE AUTO ID PLATE AP80 | Radiometer America, Inc. | Jun 9, 1989 | SESE |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | Sep 11, 1986 | SESE |
| K851528 | PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM | Pasco Laboratories, Inc. | Jul 15, 1985 | SESE |
Top Applicants
- American Micro Scan — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
- Pasco Laboratories, Inc. — 1 clearance
- Radiometer America, Inc. — 1 clearance
