Panels › Hematology › Product code GGP · Class 2
Test, Qualitative And Quantitative Factor Deficiency
Regulation 864.7290
0510(k)s in 12 months (190 all time)
2recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in GGP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2026 | Diagnostica Stago, Inc. STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
qualitative and quantitative factor deficiency test Open, Classified |
GGP | K913424 |
| Mar 3, 2026 | Diagnostica Stago, Inc. Brand Name: STA Liatest Free Protein S
Product Name: STA Liatest Free Protein S
Model/Catalog Number (REF): 00516
Product Description: The STA - Liatest Free Protein S kits are intended for use on STA Open, Classified |
GGP | K010963 |
| Mar 6, 2023 | Aniara Diagnostica LLC BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein Open, Classified |
GGP | K050365 |
| Mar 4, 2020 | Diagnostica Stago, Inc. STA - Deficient VIII, Product Code: 00725.
STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Co Terminated |
GGP | K892859 |
| Apr 4, 2017 | Helena Laboratories, Inc. "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Refer Terminated |
GGP | K972482 |
| Feb 1, 2016 | Instrumentation Laboratory Co. HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate Terminated |
GGP | K981200 |
| Dec 22, 2015 | Siemens Healthcare Diagnostics, Inc. Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency Terminated |
GGP | K884544 |
| Dec 3, 2012 | Sekisui Diagnostics Llc Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma.
Catalog # 101201.
Spectrolyse PAI-1 is in Terminated |
GGP | K063323 |
| Sep 20, 2012 | Sekisui Diagnostics Llc Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma.
Catalog Number: 101201
For the determinatio Terminated |
GGP | K063323 |
| May 10, 2012 | Instrumentation Laboratory Co. Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit
Part Number: 0020004700
The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Terminated |
GGP | K040843 |
| Apr 21, 2010 | American Diagnostica, Inc. REF 822 IMUBIND(R) Plasma PAI-1 ELISA
The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen Terminated |
GGP | K013168 |
| Aug 9, 2007 | Diagnostica Stago, Inc. STA Liatest Free Protein S
For in vitro diagnostic use.
2-8 degrees C
Distributed in the USA by:
Diagnostica Stago, Inc.
5 Century Drive
Parsippany, NJ
Phone 800-abc coag
1 - 6 x 5 ml Buffer
2 - 6 x Terminated |
GGP | K912468 |
| Jul 3, 2007 | Diagnostica Stago, Inc. STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor. Terminated |
GGP | None listed |
| Jan 20, 2006 | Diagnostica Stago, Inc. STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric Terminated |
GGP | None listed |
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