Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5715](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5715) → DDX — Plasminogen, Antigen, Antiserum, Control

# DDX · Plasminogen, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5715 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX

## Overview

- **Product Code:** DDX
- **Device Name:** Plasminogen, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5715](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5715)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## 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](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K941346.md) | PLASMINOGEN RID TEST KIT | The Binding Site, Ltd. | Sep 9, 1994 | SESE |
| [K884766](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K884766.md) | BERICHROM(R) PLASMINOGEN | Behring Diagnostics, Inc. | Jan 4, 1989 | SESE |
| [K864212](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K864212.md) | IL TEST 97573-15, PLASMINOGEN ASSAY | Instrumentation Laboratory CO | Dec 4, 1986 | SESE |
| [K854572](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K854572.md) | COATEST PLASMINOGEN | Kabivitrum, Inc. | Feb 26, 1986 | SESE |
| [K850410](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K850410.md) | GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY | Warner-Lambert Co. | May 8, 1985 | SESE |
| [K832591](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K832591.md) | DIACROM *PLG | Wellcome Diagnostics | Nov 21, 1983 | SESE |
| [K812625](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K812625.md) | ACA PLASMINOGEN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Sep 29, 1981 | SESE |
| [K811777](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K811777.md) | HELENA PLASMINOGEN QUIPLATE PROCEDURE | Helena Laboratories | Jul 2, 1981 | SESE |
| [K781478](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K781478.md) | PLASMINOGEN ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | Nov 15, 1978 | SESE |
| [K772085](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K772085.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX)

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