Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) → GIZ — Plasma, Control, Normal

# GIZ · Plasma, Control, Normal

_Hematology · 21 CFR 864.5425 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/GIZ

## Overview

- **Product Code:** GIZ
- **Device Name:** Plasma, Control, Normal
- **Regulation:** [21 CFR 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

## Classification Rationale

Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (20 of 20)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K060968](/device/K060968.md) | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW | Wortham Laboratories, Inc. | May 15, 2007 | SESE |
| [K042941](/device/K042941.md) | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dade Behring, Inc. | Dec 2, 2004 | SESE |
| [K023309](/device/K023309.md) | CONTROL PLASMA N | Dade Behring, Inc. | Nov 1, 2002 | SESE |
| [K013708](/device/K013708.md) | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Precision Biologic | Dec 10, 2001 | SESE |
| [K003328](/device/K003328.md) | ACCUCLOT CONTROL I, MODEL A4089 | Sigma Diagnostics, Inc. | Mar 1, 2001 | SESE |
| [K001256](/device/K001256.md) | CONTROL PLASMA N | Dade Behring, Inc. | May 24, 2000 | SESE |
| [K984129](/device/K984129.md) | COAGULATION CONTROL LEVEL 1 (NORMAL) | Pacific Hemostasis | Dec 1, 1998 | SESE |
| [K973274](/device/K973274.md) | ACCUCOLOR HIGH CALIBRATOR (A3089) | Sigma Diagnostics, Inc. | Oct 31, 1997 | SESE |
| [K961814](/device/K961814.md) | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Cardiovascular Diagnostics, Inc. | Aug 13, 1996 | SESE |
| [K941737](/device/K941737.md) | SPECIALTY ASSAYED CONTROL-1 | Helena Laboratories | Oct 7, 1994 | SESE |
| [K935254](/device/K935254.md) | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | American Diagnostica, Inc. | Sep 19, 1994 | SESE |
| [K924403](/device/K924403.md) | CONTROL PLASMA N | Behring Diagnostics, Inc. | Feb 22, 1994 | SESE |
| [K932145](/device/K932145.md) | COAGULATION REFERENCE PLASMA, NORMAL | American Diagnostic Corp. | Oct 18, 1993 | SESE |
| [K922021](/device/K922021.md) | UNICALIBRATOR KIT | American Bioproducts Co. | Jun 9, 1992 | SESE |
| [K905203](/device/K905203.md) | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | Dec 28, 1990 | SESE |
| [K895262](/device/K895262.md) | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | Oct 6, 1989 | SESE |
| [K893784](/device/K893784.md) | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | Jun 23, 1989 | SESE |
| [K893783](/device/K893783.md) | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | Jun 23, 1989 | SESE |
| [K891179](/device/K891179.md) | EDL NORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | Apr 10, 1989 | SESE |
| [K880712](/device/K880712.md) | CLP NORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | May 6, 1988 | SESE |

## Top Applicants

- Dade Behring, Inc. — 3 clearances
- Analytical Control Systems, Inc. — 2 clearances
- Medical Diagnostic Technologies, Inc. — 2 clearances
- Sigma Diagnostics, Inc. — 2 clearances
- American Bioproducts Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/GIZ](https://fda.innolitics.com/productcode/GIZ)

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