JTL · Plasma, Coagulase, Human, Horse And Rabbit
Microbiology · 21 CFR 866.2160 · Class 1
Overview
| Product Code | JTL |
|---|---|
| Device Name | Plasma, Coagulase, Human, Horse And Rabbit |
| Regulation | 21 CFR 866.2160 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genus Staphylococcus and provide epidemiological information on disease caused by these microorganisms.
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 the limitations in § 866.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950706 | DRYSLIDE COAGULASE | Difco Laboratories, Inc. | May 16, 1995 | SESE |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | Immuno-Mycologics, Inc. | Aug 25, 1988 | SESE |
| K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | Oxoid U.S.A., Inc. | Jun 10, 1987 | SESE |
| K861312 | LYFO-KWIK (TM) COAGULASE PLASMA | Micro-Bio-Logics | Apr 18, 1986 | SESE |
| K840553 | HEMASTAPH | Remel Co. | Apr 13, 1984 | SESE |
| K833988 | API STAPHASE III | Analytical Products, Inc. | Dec 22, 1983 | SESE |
| K833858 | COAGULASE PLASMA, HORSE & RABBIT EDTA | Otisville Biotech, Inc. | Dec 8, 1983 | SESE |
| K822988 | COAGULASE PLASMA-CITRATED & EDTA | American Scientific Products | Nov 5, 1982 | SESE |
| K820177 | COAGULASE PLASMA | Quadroma, Inc. | Feb 5, 1982 | SESE |
| K812602 | RABBIT COAGULASE PLASMA | Dutchland Laboratories, Inc. | Sep 29, 1981 | SESE |
| K811982 | STAPHASE* | Analytical Products, Inc. | Jul 28, 1981 | SESE |
| K792235 | COAGULASE PLASMA | Remel Co. | Dec 7, 1979 | SESE |
Top Applicants
- Analytical Products, Inc. — 2 clearances
- Remel Co. — 2 clearances
- American Scientific Products — 1 clearance
- Difco Laboratories, Inc. — 1 clearance
- Dutchland Laboratories, Inc. — 1 clearance
