DDX · Plasminogen, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5715 · Class 1
Overview
| Product Code | DDX |
|---|---|
| Device Name | Plasminogen, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5715 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.
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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K941346 | PLASMINOGEN RID TEST KIT | The Binding Site, Ltd. | Sep 9, 1994 | SESE |
| K884766 | BERICHROM(R) PLASMINOGEN | Behring Diagnostics, Inc. | Jan 4, 1989 | SESE |
| K864212 | IL TEST 97573-15, PLASMINOGEN ASSAY | Instrumentation Laboratory CO | Dec 4, 1986 | SESE |
| K854572 | COATEST PLASMINOGEN | Kabivitrum, Inc. | Feb 26, 1986 | SESE |
| K850410 | GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY | Warner-Lambert Co. | May 8, 1985 | SESE |
| K832591 | DIACROM *PLG | Wellcome Diagnostics | Nov 21, 1983 | SESE |
| K812625 | ACA PLASMINOGEN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Sep 29, 1981 | SESE |
| K811777 | HELENA PLASMINOGEN QUIPLATE PROCEDURE | Helena Laboratories | Jul 2, 1981 | SESE |
| K781478 | PLASMINOGEN ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | Nov 15, 1978 | SESE |
| K772085 | LAS-R HUMAN PLASMINOGEN TEST | Hyland Therapeutic Div., Travenol Laboratories | Jan 24, 1978 | SESE |
Top Applicants
- Wellcome Diagnostics — 1 clearance
- Warner-Lambert Co. — 1 clearance
- The Binding Site, Ltd. — 1 clearance
- Kabivitrum, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
