DIAGNOSTICA STAGO, INC.

FDA Device Registration & Listing · PARSIPPANY, NJ, US · Registration 2245451

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2245451
FEI Number
2245451
Entity Name
DIAGNOSTICA STAGO, INC.
City/State/Country
PARSIPPANY, NJ, US
Establishment Address
5 Century Dr, PARSIPPANY, NJ 07054, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Diagnostica Stago, Inc. (Owner Number: 9003476)
Owner / Operator Contact Address
5 Century Drive, Sute 200, Parsippany, NJ 07054, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K854016
PMA Number
N/A

All Registered Proprietary Names

FDP Plasma Latex FDP Plasma FDP Plasma Buffer Stachrom Heparin Asserachrom HPIA - IgG STA - FM Control STA - Fondaparinux Control STA - Liatest D-Di STA - Control LA 1 + 2 PTT Automate 5 STA - PTT A 5 STA Satellite STA - Neoplastine CI Plus 5 STA - Neoplastine CI Plus 10 STA - System Control N + P System Control N + P STA - Reptilase STA - Staclot APC-R vWF Ag Asserachrom Free Protein S STA - Hepanorm H Staclot LA Staclot LA 20 TriniCHECK D-Dimer 1 TriniCLOT Lupus Confirm TriniCHROM Antithrombin Xa D-Di Test Test cards for D-Di Test kit STA - Stachrom Protein C Asserachrom Total Protein S STA - Liatest FM Asserachrom HPIA STA - Staclot Protein C 1 STA - Staclot Protein C 3 Unicalibrator STA - Unicalibrator STA - Deficient V STA - Quality HNF/UFH STA - Multi Hep Calibrator STA - Liquid Anti-Xa 8 STA - Quality HBPM/LMWH STA - Liquid Anti-Xa 4 STA - Dabigatran Control STA - Dabigatran Calibrator TriniCHECK D-Dimer 3 TriniCHECK D-Dimer 2 Asserachrom APA Screen Asserachrom APA IgG,M TriniCLOT Lupus Screen Liatest AT III STA - Liatest Free Protein S 2 STA - Liatest Free Protein S 6 STA Coag Expert STA Coag Connexion SCE upgrade to Coag.One server license Coag.One server license TriniCLOT aPTT S 10 ml TriniCLOT aPTT S 3 ml STA-R Evolution/Expert Series(XP)/E5 + cap piercing STA-R Evolution/Expert Series(XP)/E5 STA R Max + cap piercing STA R Max Asserachrom D-Di K-ASSAY FACTOR XIII K-ASSAY FACTOR XIII CALIBRATOR K-ASSAY FACTOR XIII CONTROL TriniCHROM Antithrombin IIa STA - Staclot Heparin 1 STA - NeoPTimal 5 STA - NeoPTimal 20 STA - NeoPTimal 10 STA - Liatest D-Di STA-R Evolution/Expert Series(XP)/E5 STA R Max + cap piercing STA R Max STA-R Evolution/Expert Series(XP)/E5 + cap piercing STA - Stachrom Plasminogen STA - VWF:Ag Calibrator Asserachrom PF4 TriniCLOT Calcium Chloride 025 M STA Compact Max + cap piercing STA Compact Max TriniLIZE PAI-1 Activity STA - Deficient VIII Liatest Protein S STA - Deficient X STA - Liatest D-Di TriniCLOT Factor X STA - Heparin Control PTT-LA TriniCLOT Thrombin Time TriniCLOT Factor VII STA - ImmunoDef VIII STA - ImmunoDef XII STA - ImmunoDef IX STA - ImmunoDef II STA - ImmunoDef XI KC1 STA - NeoPTimal 10 STA - NeoPTimal 5 TriniCHROM Factor VIII:C TriniCLOT PT Excel S 6 ml TriniCLOT PT Excel S 20 ml TriniCAL Reference Plasma TriniCHECK Abnormal Control TriniCHROM Antithrombin IIa STA - Staclot dRVV Screen 2 STA - Staclot dRVV Confirm STA - Staclot dRVV Screen 5 STA - Deficient XI TriniCAL Reference Plasma TriniCLOT Factor IX Destiny Plus STA - Deficient VII STA - Stachrom AT III 3 STA - Stachrom AT III 6 TriniCLOT aPTT HS 10 ml TriniCLOT aPTT HS 3 ml F.S. Test F.S. Test Unit Test cards for F.S. Test and FDP Plasma kits Asserachrom tPA STA - Liatest VWF:Ag STA - HBPM/LMWH Control TriniCLOT Factor II Asserachrom b-TG TriniCLOT Factor XI KC4 Asserachrom VWF:Ag STA Satellite Max STA - Coag Control (N + ABN) PLUS Asserachrom VWF:FVIIIB Stachrom PAI Asserachrom VWF:CB STA - VWF:Rco Destiny Max TriniCLOT Factor VIII TriniCLOT Factor XII STA - Quality HBPM/LMWH Ristocetin STA - Hepanorm HBPM/LMWH Asserachrom Protein C

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2020-12-23
KFF Assay, Heparin Hematology Class 2 864.7525 2021-01-15
DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5660 2017-01-04
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-01-04
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2020-12-31
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2020-12-21
GGC Control, Plasma, Abnormal Hematology Class 2 864.5425 2020-12-21
GGW Test, Time, Partial Thromboplastin Hematology Class 2 864.7925 2021-01-27
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-27
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2021-01-23
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2020-12-31
GGC Control, Plasma, Abnormal Hematology Class 2 864.5425 2020-12-31
JCO Bothrops Atrox Reagent Hematology Class 2 864.8100 2020-12-31
GGW Test, Time, Partial Thromboplastin Hematology Class 2 864.7925 2017-01-04
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2023-06-05
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
KFF Assay, Heparin Hematology Class 2 864.7525 2020-12-31
GFO Activated Partial Thromboplastin Hematology Class 2 864.7925 2020-12-23
GIZ Plasma, Control, Normal Hematology Class 2 864.5425 2021-01-22
GIR Reagent, Russel Viper Venom Hematology Class 1 864.8950 2021-01-22
JBQ Antithrombin Iii Quantitation Hematology Class 2 864.7060 2021-01-22
GHH Fibrin Split Products Hematology Class 2 864.7320 2020-12-23
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
JBN Fibrin Monomer Paracoagulation Hematology Class 2 864.7300 2017-01-04
LCO Platelet Factor 4 Radioimmunoassay Hematology Class 2 864.7695 2020-12-31
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
GIZ Plasma, Control, Normal Hematology Class 2 864.5425 2020-12-31
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2021-01-28
KFF Assay, Heparin Hematology Class 2 864.7525 2020-12-23
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2020-12-23
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2020-12-23
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2018-09-17
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2021-01-22
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2021-01-22
OTR Research Use Only/Immunology Devices Unknown Class N N/A 2017-01-04
GIR Reagent, Russel Viper Venom Hematology Class 1 864.8950 2021-01-22
JBQ Antithrombin Iii Quantitation Hematology Class 2 864.7060 2020-12-23
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2021-01-15
GFO Activated Partial Thromboplastin Hematology Class 2 864.7925 2021-01-22
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2021-01-15
DBT Factor Xiii A, S, Antigen, Antiserum, Control Immunology Class 1 866.5330 2021-01-22
JBQ Antithrombin Iii Quantitation Hematology Class 2 864.7060 2021-01-22
KFF Assay, Heparin Hematology Class 2 864.7525 2021-01-15
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2019-05-02
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2020-12-31
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
DDX Plasminogen, Antigen, Antiserum, Control Immunology Class 1 866.5715 2020-12-31
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-27
LCO Platelet Factor 4 Radioimmunoassay Hematology Class 2 864.7695 2021-01-15
GFO Activated Partial Thromboplastin Hematology Class 2 864.7925 2021-01-22
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-22
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-27
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2020-12-31
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
KFF Assay, Heparin Hematology Class 2 864.7525 2020-12-31
GGW Test, Time, Partial Thromboplastin Hematology Class 2 864.7925 2021-01-27
KQJ System, Fibrinogen Determination Hematology Class 2 864.7340 2021-01-22
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2018-09-17
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2024-03-21
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-28
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2021-01-28
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
GGC Control, Plasma, Abnormal Hematology Class 2 864.5425 2021-01-22
JBQ Antithrombin Iii Quantitation Hematology Class 2 864.7060 2021-01-22
GIR Reagent, Russel Viper Venom Hematology Class 1 864.8950 2020-12-23
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-27
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2021-01-28
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-27
JBQ Antithrombin Iii Quantitation Hematology Class 2 864.7060 2020-12-23
GIT Reagent & Control, Partial Thromboplastin Time Hematology Class 2 864.7925 2021-01-22
JBN Fibrin Monomer Paracoagulation Hematology Class 2 864.7300 2021-01-27
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-27
KFF Assay, Heparin Hematology Class 2 864.7525 2020-12-31
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
JBX Aggregrometer, Platelet Hematology Class 2 864.6675 2021-01-15
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2021-01-23
KQJ System, Fibrinogen Determination Hematology Class 2 864.7340 2026-05-28
GGW Test, Time, Partial Thromboplastin Hematology Class 2 864.7925 2026-05-28
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2026-05-28
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2026-05-28
KFF Assay, Heparin Hematology Class 2 864.7525 2026-05-28
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2026-05-28
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2020-12-31
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2017-01-04
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-01-28
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2021-01-28
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2020-12-31
GHR Reagent, Platelet Aggregation Hematology Class 2 864.5700 2021-01-15
KFF Assay, Heparin Hematology Class 2 864.7525 2020-12-31
JLA Conversion To Creatinine, Creatine Clinical Chemistry Class 1 862.1210 2021-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diagnostica Stago, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151534 Instrumentation Laboratory CO HemosIL D-Dimer HS 2015-07-06
K160885 Instrumentation Laboratory CO HemosIL D-Dimer HS 2016-10-27
K980242 Instrumentation Laboratory CO IL TEST HEPARIN 1998-03-19
K820088 Calbiochem-Behring Corp. AFT SYSTEM PROFICIENCY TESTING PROGRAM 1982-01-26
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2008 Diagnostica Stago, Inc. 2
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0514-2014 Instrumentation Laboratory Co. 2
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014 Instrumentation Laboratory Co. 2
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014 Instrumentation Laboratory Co. 2
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245451. Last updated year: 2026. Please use registration number 2245451 when referencing this establishment in official correspondence.
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