Company · US
Diagnostica Stago, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2026. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (2 in 12 months)
42recalls (4 in 12 months)
34recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 12 |
| GJS | Test, Time, Prothrombin | 9 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 8 |
| KFF | Assay, Heparin | 6 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 5 |
| GGN | Plasma, Coagulation Control | 5 |
| GFO | Activated Partial Thromboplastin | 4 |
| GKP | Instrument, Coagulation, Automated | 3 |
| LCO | Platelet Factor 4 Radioimmunoassay | 2 |
| GGC | Control, Plasma, Abnormal | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 |
| GIR | Reagent, Russel Viper Venom | 1 |
| GIZ | Plasma, Control, Normal | 1 |
| GJT | Plasma, Coagulation Factor Deficient | 1 |
| JIT | Calibrator, Secondary | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JOX | Analyzer, Heparin, Automated | 1 |
| KQJ | System, Fibrinogen Determination | 1 |
| PPM | General Purpose Reagent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K260214 | STA® - Liquid Anti-Xa Diagnostica Stago, Inc. | KFF |
| Apr 27, 2026 | K253658 | STA Satellite Max® Diagnostica Stago, Inc. | JPA |
| Dec 10, 2016 | K162227 | STA® - Liatest® D-Di Diagnostica Stago, FR | DAP |
| Sep 3, 2014 | K141144 | STA LIATEST D-DI Diagnostica Stago, IT | DAP |
| Mar 14, 2013 | K120014 | STA- COAG CONTROL (N+ABN) PLUS Diagnostica Stago, Inc. | GGN |
| Feb 12, 2013 | K130090 | STA COMPACT MAX Diagnostica Stago, Incorporated, IT | JPA |
| Oct 26, 2011 | K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH Diagnostica Stago, Inc., IT | KFF |
| Aug 2, 2010 | K092937 | STA-HYBRID HEP CALIBRATOR Diagnostica Stago, Inc. | JIT |
| Dec 22, 2009 | K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER Diagnostica Stago, Inc. | JPA |
| Dec 22, 2009 | K092170 | STA LIATEST FREE PS Diagnostica Stago, Inc. | GGP |
| Dec 18, 2009 | K093001 | STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER Diagnostica Stago, Incorporated | JPA |
| Nov 13, 2009 | K092113 | STA - FREE PS CALIBRATOR Diagnostica Stago, Inc. | JIX |
| Dec 12, 2008 | K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER Diagnostica Stago, Inc. | JPA |
| Oct 10, 2008 | K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER Diagnostica Stago, Inc. | JPA |
| Dec 6, 2006 | K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM Diagnostica Stago, Inc. | GIR |
| Jul 28, 2006 | K061803 | STA - CONTROL LA 1+2 Diagnostica Stago, Inc. | GGC |
| May 4, 2006 | K053111 | STA-CEPHASCREEN KIT Diagnostica Stago, Inc. | GFO |
| Jun 7, 2001 | K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN Diagnostica-Stago | KFF |
| Jun 6, 2001 | K010963 | STA-LIATEST FREE PROTEIN S TEST KIT Diagnostica Stago, Inc. | GGP |
| Apr 9, 2001 | K010350 | STA -CALIBRATOR HBPM/LMWH KIT Diagnostica Stago, Inc. | GGN |
| Apr 9, 2001 | K010324 | STA-QUALITY HBPM/LMWH KIT Diagnostica Stago, Inc. | GGN |
| Feb 12, 2001 | K003767 | ASSERACHROM HPIA TEST KIT Diagnostica Stago, Inc. | LCO |
Latest recalls
| 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 19, 2026 | Diagnostica Stago, Inc. Brand Name: STA Liatest D-Di
Product Name: STA Liatest D-Di
Model/Catalog Number: REF 00515
Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative det Open, Classified |
DAP | K162227 |
| 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 |
| Jan 14, 2026 | Diagnostica Stago, Inc. Asserachrom HPIA.
Model/Catalog Number: 00615.
The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated Open, Classified |
LCO | K003767 |
| Oct 16, 2025 | Diagnostica Stago, Inc. Product: STA Liatest D-Di;
REF: 00515; Open, Classified |
DAP | K141144 K162227 +1 |
| Aug 28, 2025 | Diagnostica Stago, Inc. STA - Fibrinogen 5. Model/Catalog Number: 00674.
The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determina Open, Classified |
KQJ | K840211 |
| Aug 28, 2025 | Diagnostica Stago, Inc. STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the Open, Classified |
KFF | K111822 |
| Aug 28, 2025 | Diagnostica Stago, Inc. STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the Open, Classified |
KFF | K111822 |
| Aug 28, 2025 | Diagnostica Stago, Inc. STA Satellite. Product Code: All references. All software versions.
The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologi Open, Classified |
JPA | K082248 |
| Jun 18, 2025 | Diagnostica Stago, Inc. STA - Owren Koller. Model/Catalog Number: 00360
STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of t Open, Classified |
PPM | None listed |
| May 10, 2023 | Diagnostica Stago, Inc. STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 Open, Classified |
JPA | K130090 |
| May 10, 2023 | Diagnostica Stago, Inc. STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 Open, Classified |
JPA | K093167 |
| May 10, 2023 | Diagnostica Stago, Inc. STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 Open, Classified |
JPA | K151867 |
| 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 |
| Dec 23, 2019 | Diagnostica Stago, Inc. STA SYSTEM CONROL N + P (ref. 00678) Terminated |
GGN | K943518 |
| Dec 23, 2019 | Diagnostica Stago, Inc. STA UNICALIBRATOR (ref. 00675) Terminated |
GIZ | K922021 |
| Nov 14, 2018 | Diagnostica Stago, Inc. Staclot LA 20 (REF 00594)
The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII pha Terminated |
GFO | K923731 |
| Nov 14, 2018 | Diagnostica Stago, Inc. Staclot LA (REF 00600)
The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase Terminated |
GFO | K923731 |
| Jul 24, 2018 | Diagnostica Stago, Inc. Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.
REF: 00666
The STA - Noplastine CI kits provide reagents for the determ Terminated |
GJS | K922565 |
| Jul 24, 2018 | Diagnostica Stago, Inc. Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.
(REF 00667)
The STA - Noplastine CI Plus kits provide reagents fo Terminated |
GJS | K922040 |
| Oct 25, 2017 | Diagnostica Stago, Inc. STA - Neoplastine Cl Plus (ref. 00606)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922040 |
| Oct 25, 2017 | Diagnostica Stago, Inc. STA - Neoplastine Cl (ref. 00605)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922565 |
| Oct 25, 2017 | Diagnostica Stago, Inc. Neoplastine Cl Plus (ref. 00375)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922040 |
| Oct 25, 2017 | Diagnostica Stago, Inc. Neoplastine Cl Plus @ (ref.00374)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922040 |
| Sep 16, 2014 | Diagnostica Stago, Inc. Stago IVD, Liquid Anti-Xa, NDC 3607450003116.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma l Terminated |
KFF | K111822 |
| Mar 14, 2013 | Diagnostica Stago, Inc. Vial Label:
1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago
2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago
3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago
Model, catalogue, number 00 Terminated |
GJT | K962675 |
| Nov 6, 2012 | Diagnostica Stago, Inc. STA Satellite Automated Multi-Parameter Analyzer
This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in Terminated |
JPA | K082248 |
| Feb 16, 2012 | Diagnostica Stago, Inc. STA - System Control N + P
Product Usage:
The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on Terminated |
GGN | K943518 |
| Dec 18, 2008 | Diagnostica Stago, Inc. STA Neoplastine CI Plus 10; Product Catalogue Number: 0667
Manufactured by Diagnostica Stago, Asnieres, France. Terminated |
GJS | None listed |
| Dec 18, 2008 | Diagnostica Stago, Inc. STA Neoplastine CI 10; Product Catalogue Number: 0666;
Manufactured by Diagnostica Stago, Asnieres, France. Terminated |
GJS | None listed |
| Oct 11, 2007 | Diagnostica Stago, Inc. STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic. Terminated |
GKP | K961579 |
| 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 Neoplastine CI Plus (10), (cat. 0667).
12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT). Terminated |
GJS | K922040 |
| 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 |
| May 16, 2007 | Diagnostica Stago, Inc. STA Compact and STA Compact CT
For in vitro Diagnostic Use Only
In vitro diagnostic analyzer
Diagnostica Stago
France Terminated |
GKP | K961579 |
| Aug 26, 2006 | Diagnostica Stago, Inc. Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay. Terminated |
GFO | K923731 |
| 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 |
| Aug 30, 2005 | Diagnostica Stago, Inc. STA-R blood coagulation analyzer. Catalog Number 57160. Terminated |
JPA | None listed |
| Aug 30, 2005 | Diagnostica Stago, Inc. PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054. Terminated |
GGW | K921684 |
| Jul 20, 2004 | Diagnostica Stago, Inc. FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies Terminated |
DAP | None listed |
| Jul 20, 2004 | Diagnostica Stago, Inc. STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for th Terminated |
JOX | None listed |
| May 29, 2003 | Diagnostica Stago, Inc. STA-Compact Hemostasis System with Cap piercing capability. Terminated |
GKP | K961579 K983460 |