JSP · Kit, Anaerobic Identification
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JSP |
|---|---|
| Device Name | Kit, Anaerobic Identification |
| 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945489 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | May 11, 1995 | SESE |
| K945488 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | May 11, 1995 | SESE |
| K945487 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | May 11, 1995 | SESE |
| K944528 | BBLCRYSTAL ANAEROBE ID SYSTEM | Becton Dickinson Microbiology Systems | Mar 7, 1995 | SESE |
| K910666 | VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION | Vitek Systems, Inc. | Apr 3, 1991 | SESE |
| K900996 | VITEK ANAEROBE IDENTIFICATION CARD | Vitek Systems, Inc. | May 11, 1990 | SESE |
| K881380 | B. FRAGTEX | American Biomedical Products, Inc. | Oct 6, 1988 | SESE |
| K882960 | IDS RAPID ANA SYSTEM | Innovative Diagnostic Systems, Inc. | Aug 12, 1988 | SESE |
| K855235 | DIAGNOSTIC REAGENT PET-RPLA | Oxoid U.S.A., Inc. | Nov 4, 1986 | SESE |
| K862332 | ANAEROBE RAPID CHROMOGENIC ID PANEL | American Micro Scan | Aug 27, 1986 | SESE |
| K850052 | ANAEROBE KIT | Austin Biological Laboratories | Mar 5, 1985 | SESE |
| K843686 | AMS ANA CARD | Vitek Systems, Inc. | Dec 12, 1984 | SESE |
| K831032 | API ANAIDENT | Analytical Products, Inc. | May 5, 1983 | SESE |
| K830964 | ANAEROBE MIC/ID TEMPLATE, & TAXONOMY | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 4, 1983 | SESE |
| K820483 | IDA RAPID O2A SYSTEM | Innovative Diagnostic Systems, Inc. | Mar 15, 1982 | SESE |
| K802626 | ANAIROBE-TEK | Flow Laboratories, Inc. | Nov 12, 1980 | SESE |
| K801547 | TEST PANEL FOR PRESUMP. ID/BACT. ORG | Micro-Media Systems, Inc. | Sep 9, 1980 | SESE |
| K771616 | API 20A | Analytical Products, Inc. | Sep 2, 1977 | SESE |
Top Applicants
- Microbiologics, Inc. — 3 clearances
- Vitek Systems, Inc. — 3 clearances
- Analytical Products, Inc. — 2 clearances
- Innovative Diagnostic Systems, Inc. — 2 clearances
- American Biomedical Products, Inc. — 1 clearance
