Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7290](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7290) → GGP — Test, Qualitative And Quantitative Factor Deficiency

# GGP · Test, Qualitative And Quantitative Factor Deficiency

_Hematology · 21 CFR 864.7290 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP

## Overview

- **Product Code:** GGP
- **Device Name:** Test, Qualitative And Quantitative Factor Deficiency
- **Regulation:** [21 CFR 864.7290](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7290)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Recent Cleared Devices (20 of 190)

Showing 20 most recent of 190 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251440](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K251440.md) | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | Aug 25, 2025 | SESE |
| [K230852](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K230852.md) | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | Dec 13, 2023 | SESE |
| [K220728](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K220728.md) | vWF Ag | Siemens Healthcare Diagnostics Products GmbH | Jun 2, 2023 | SESE |
| [K214002](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K214002.md) | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | Dec 23, 2022 | SESE |
| [K223402](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K223402.md) | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | Dec 9, 2022 | SESE |
| [K200033](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K200033.md) | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | Aug 19, 2020 | SESE |
| [K193204](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K193204.md) | Cryocheck Chromogenic Factor VIII | Precision Biologic | Jul 17, 2020 | SESE |
| [K183440](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K183440.md) | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | Mar 12, 2019 | SESE |
| [K181525](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K181525.md) | INNOVANCE Free PS Ag | Siemens Healthcare Diagnostics Products GmbH | Sep 7, 2018 | SESE |
| [K133005](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K133005.md) | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | Instrumentation Laboratory CO | Mar 13, 2014 | SESE |
| [K102164](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K102164.md) | HEMOSIL PROTEIN S ACTIVITY ASSAY | Instrumentation Laboratory CO | Mar 17, 2011 | SESE |
| [K092170](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K092170.md) | STA LIATEST FREE PS | Diagnostica Stago, Inc. | Dec 22, 2009 | SESE |
| [K082631](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K082631.md) | THROMBO TEK PSE, MODEL 90-480 | R2 Diagnostics, Inc. | Dec 17, 2008 | SESE |
| [K082205](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K082205.md) | FACTOR VIII ANTIBODY SCREEN | Genetic Testing Institute | Nov 20, 2008 | SESE |
| [K063323](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K063323.md) | SPECTROLYSE PAI-1, MODEL 101201 | American Diagnostica, Inc. | Aug 15, 2007 | SESE |
| [K070635](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K070635.md) | HEMOSIL PROCLOT | Instrumentation Laboratory CO | Mar 29, 2007 | SESE |
| [K062530](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K062530.md) | TRIAGE PROTEIN C TEST | Biosite Incorporated | Jan 29, 2007 | SESE |
| [K062430](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K062430.md) | HEMOSIL PROTEIN C | Instrumentation Laboratory CO | Sep 1, 2006 | SESE |
| [K052825](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K052825.md) | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | Affinity Biologicals, Inc. | Jan 20, 2006 | SESE |
| [K053499](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K053499.md) | HEMOSIL PROS | Instrumentation Laboratory CO | Jan 13, 2006 | SESE |

## Top Applicants

- Instrumentation Laboratory CO — 27 clearances
- American Bioproducts Co. — 22 clearances
- Helena Laboratories — 17 clearances
- American Dade — 9 clearances
- Biopool AB — 9 clearances

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP)

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