Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1217183

FEI Number

1217183

Entity Name

INSTRUMENTATION LABORATORY CO.

City/State/Country

Bedford, MA, US

Establishment Address

180 Hartwell Rd., Bedford, MA 01730, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Instrumentation Laboratory Co. (Owner Number: 1217183)

Owner / Operator Contact Address

180 Hartwell Road, --, Bedford, MA 01730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K951485

PMA Number

N/A

All Registered Proprietary Names

85053-10 - Aspirin Test 85053 - Aspirin Test HE-ESV - Electronic System Verification Tube HR1003 - Temperature Verification Tube HemosIL D-Dimer HemosIL von Willebrand Factor Activity GEM Premier 4000 GEM Premier 5000 (Instrument) GEM Premier 5000 PAK HemosIL Apixaban Controls HemosIL D-Dimer Controls ROTROL P, ROTROL N HemosIL Rivaroxaban Controls HemosIL CL Multi-Ab Controls GEM Premier ChemSTAT GEM Premier ChemSTAT PAK HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG HemosIL AcuStar Anti-B2 Glycoprotein-I IgM HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls HemosIL D-Dimer Controls HemosIL Homocysteine Controls HemosIL Homocysteine HEMOSIL FACTOR XIII ANTIGEN HemosIL Plasma Coagulation Control Level 1 HemosIL Plasma Coagulation Control Level 2 HemosIL Rivaroxaban Controls HemosIL Apixaban Controls HemosIL Dabigatran Controls 85310 - IIb/IIIa Test J103 - APTT Cuvettes R-HRT480P - Heparin Response Test RQCHRT - RxDx Whole Blood Quality Control Heparin HemosIL Chromogenic Factor IX HemosIL Free Protein S HemosIL D-Dimer HS GH100L - GEM Hemochron 100 System GH100 - GEM Hemochron 100 System HE-J04 - Hemochron Electronic System Verification Kit JEN-QC - Hemochron Electronic System Verification, Normal JEA-QC - Hemochron Electronic System Verification, Abnormal HRDM3CD - Hemochron Data Manager V3 J-1001 - Hemochron Temperature Verification Cartrdige GEM Premier 4000 ROTEM sigma ROTROL N ROTEM sigma complete + hep ROTEM sigma ROTROL P ROTEM sigma Thromboelastometry System GEM Premier ChemSTAT GEM Premier ChemSTAT PAK TL100I - Tenderlett Finger Incision Device TL5000I - Tenderlett Finger Incision Device ACL AcuStar ACL TOP 970 CL HemosIL von Willebrand Factor Antigen GEM CVP 2 with CO-OX (Orangeburg NY Facility) GEM CVP 3 Hematocrit (Orangeburg NY Facility) GEM CVP 1 with CO-OX (Orangeburg NY Facility) GEM CVP 5 tBili (Orangeburg NY Facility) GEM CVP 4 Hematocrit (Orangeburg NY Facility) GEM Premier 4000 PAK (Bedford MA Facility) GEM Premier 4000 (Bedford MA Facility) R-PRT200 - Celite Protamine Response Test RQCPRT - RxDx Whole Blood Quality Control Protamine R-PRT400 - Celite Protamine Response Test ACL TOP 300 CTS ACL TOP CTS (Refurb) ACL TOP 500 CTS ACL TOP 700 (Refurb) ACL TOP 700 CTS ACL TOP 700 ACL TOP 700 LAS ACL TOP 700 CTS (Refurb) ACL TOP 500 CTS (Refurb) ACL TOP 300 CTS (Refurb) HemosIL CL HIT-IgG(PF4-H) HemosIL D-Dimer HS 500 Controls NATEM Assay ROTROL N ROTEM Delta Instrument hep-TEM Assay star-TEM ROTROL P in-TEM Assay GEM Premier 5000 PAK SU50I - Surgicutt Bleeding Time Device R-PRT200K - Kaolin Protamine Response Test R-PRT400K - Kaolin Protamine Response Test PDAOK - Kaolin Protamine Dose Assay R-HRT480PK - Kaolin Heparin Response Test HemosIL D-Dimer HS DCJLR-N - directCHECK ACT-LR-Normal DCJLR-A - directCHECK ACT-LR-Abnormal DCJ-005 - Protective Sleeves DCJACT-A - directCHECK ACT+-Abnormal DCJACT-N - directCHECK ACT+-Normal GEM Premier ChemSTAT GEM ChemSTAT HemosIL AcuStar D-Dimer HemosIL AcuStar D-Dimer Controls AcuStar BIO-FLASH J201 - PT Cuvettes J201C - Citrate PT Cuvettes GEM Premier 5000 PAK J103C - Citrate APTT Cuvettes 85064 - P2Y12 Test, International 85425 - P2Y12 Test, International 85064-PRO - P2Y12 Test, International HemosIL AcuStar Anti-B2GPI Domain 1 Control Test Tube HemosIL Fibrinogen-C HemosIL Fibrinogen-C XL DCJCAPTT-A - directCHECK Citrate APTT-Abnormal DCP214-N - HepCheck P214-Normal DCJAPTT-A - directCHECK APTT-Abnormal DCP214-A - HepCheck P214-Abnormal DCJPT-N - directCHECK PT-Normal DCJAPTT-N - directCHECK APTT-Normal DCJPT-A - directCHECK PT-Abnormal DCJCPT-N - directCHECK Citrate PT-Normal DCJCPT-A - directCHECK Citrate PT-Abnormal HemosIL AcuStar HIT-IgG(PF4-H) HemosIL AcuStar HIT Controls HemosIL CL Anti-B2 Glycoprotein-I IgM ACL TOP 970 CL HemosIL CL Anti-Cardiolipin IgM PDAO - Celite Protamine Dose Assay HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgG HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL AcuStar Anti-Cardiolipin IgM JACT+ - ACT+ Cuvettes HemosIL D-Dimer HS 500 Controls TFP50I - Tenderfoot Preemie Heel Incision Device TF1000I - Tenderfoot Newborn Heel Incision Device TFP1000I - Tenderfoot Preemie Heel Incision Device TF50I - Tenderfoot Newborn Heel Incision Device TFT50I - Tenderfoot Toddler Heel Incision Device TF200I - Tenderfoot Newborn Heel Incision Device TFM50I - Tenderfoot Micro-Preemie Heel Incision Device TFP200I - Tenderfoot Preemie Heel Incision Device GEM CVP 4 GEM CVP 1 GEM CVP Multipak GEM CVP 3 GEM Premier 3000 PAK GEM Premier 3500/3000 PAK GEM CVP 2 AVOX4000D - Whole Blood CO-Oximeter Instrument AVOX4000RF - Whole Blood CO-Oximeter Instrument 4-QCYO - Whole Blood CO-Oximeter Optical QC Filters AVOX4000 - Whole Blood CO-Oximeter Instrument QV8 - Avoximeter 4000 Cuvettes 4-TMPB - Whole Blood CO-Oximeter Temperature Probe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2025-02-24
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-24
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-12-26
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2011-09-21
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2011-09-21
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2011-09-21
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-09-21
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2021-08-30
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2021-08-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-08-30
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2021-08-30
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2021-08-30
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2021-08-30
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2021-08-30
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2021-08-30
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2021-08-30
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2021-08-30
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2021-08-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2021-08-30
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2021-06-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2019-06-25
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2019-06-25
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2019-06-25
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2019-06-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2019-06-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-09-21
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2011-09-21
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-12-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-03
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2007-12-03
DBT	Factor Xiii A, S, Antigen, Antiserum, Control	Immunology	Class 1	866.5330	2005-09-20
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-12
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2025-02-24
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-24
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2025-02-24
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2024-04-11
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-26
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2020-10-06
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-28
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2025-02-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-02-28
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-24
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2023-07-25
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2023-07-25
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2023-07-25
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2023-07-25
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2023-07-25
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2023-07-25
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2023-07-25
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2023-07-25
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2023-07-25
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2023-07-25
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-07-25
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-07-25
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-07-25
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-28
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-03-02
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2023-03-02
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2023-03-02
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2023-03-02
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2023-03-02
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2023-03-02
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2023-03-02
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-03-02
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-03-02
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2023-03-02
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2023-03-02
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-02-24
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2018-02-20
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2024-04-11
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2024-04-11
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-11-02
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-12-26
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-12-26
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2012-12-26
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2012-12-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-12-26
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-12-26
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2012-12-26
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-12-26
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-12-26
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2012-12-26
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2012-12-26
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-12-26
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2012-12-26
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2012-12-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-12-26
GFT	Protamine Sulphate	Hematology	Class 2	864.7525	2025-02-24
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2016-06-22
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	Class 2	864.7695	2025-09-12
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-26
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-12-26
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-02-28
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2017-02-14
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2017-02-14
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-02-14
JCA	Device, Bleeding Time	Hematology	Class 2	864.6100	2025-02-24
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2025-02-24
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-12-03
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-02-24
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2019-07-11
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2019-07-11
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2019-07-11
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2019-06-25
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2019-06-25
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2019-06-25
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2019-06-25
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2011-12-12
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2011-12-12
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2011-12-12
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2025-02-24
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2025-02-24
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2017-02-14
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-24
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2025-02-24
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2025-02-24
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2019-07-10
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-02-24
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2025-12-16
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-02-24
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2018-02-05
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	Class 2	864.7695	2018-02-05
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2024-04-11
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2024-04-11
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2024-04-11
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-02-24
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2010-03-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-03-18
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2025-02-24
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2015-06-29
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-02-28
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-12-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-12-26
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2025-02-24

Official Correspondent

Carol Marble

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Instrumentation Laboratory Co.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K151534	Instrumentation Laboratory CO	HemosIL D-Dimer HS	2015-07-06
K160885	Instrumentation Laboratory CO	HemosIL D-Dimer HS	2016-10-27
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400
Z-0077-2019	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Z-0135-2011	Instrumentation Laboratory Co.	2	ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-0136-2011	Instrumentation Laboratory Co.	2	ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-0137-2011	Instrumentation Laboratory Co.	2	ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-0138-2011	Instrumentation Laboratory Co.	2	ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
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
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer
Z-0736-2016	Instrumentation Laboratory Co.	2	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
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0803-2011	Instrumentation Laboratory Co.	2	ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.
Z-0804-2011	Instrumentation Laboratory Co.	2	ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.
Z-0805-2011	Instrumentation Laboratory Co.	2	ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing.
Z-0806-2011	Instrumentation Laboratory Co.	2	ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.
Z-0807-2011	Instrumentation Laboratory Co.	2	ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.
Z-0832-2015	Instrumentation Laboratory Co.	2	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Z-0846-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
Z-0895-2018	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Z-0915-05	Instrumentation Laboratory Co.	2	ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
Z-1127-2007	Instrumentation Laboratory Co.	2	Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000
Z-1246-06	Instrumentation Laboratory Co.	2	HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
Z-1247-06	Instrumentation Laboratory Co.	2	Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
Z-1519-2012	Instrumentation Laboratory Co.	2	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 Activity) in human citrated plasma on IL Coagulation Systems
Z-1784-2013	Instrumentation Laboratory Co.	2	HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Z-2060-2014	Instrumentation Laboratory Co.	2	ACL TOP (Base), automated coagulation laboratory instrument.
Z-2061-2014	Instrumentation Laboratory Co.	2	ACL TOP 700, automated coagulation laboratory instrument.
Z-2062-2014	Instrumentation Laboratory Co.	2	ACL TOP CTS, automated coagulation laboratory instrument.
Z-2063-2014	Instrumentation Laboratory Co.	2	ACL TOP 700 LAS, automated coagulation laboratory instrument.
Z-2064-2014	Instrumentation Laboratory Co.	2	ACL TOP 500 CTS, automated coagulation laboratory instrument.
Z-2065-2014	Instrumentation Laboratory Co.	2	ACL TOP 700 CTS, automated coagulation laboratory instrument.
Z-2066-2014	Instrumentation Laboratory Co.	2	ACL TOP 300 CTS, automated coagulation laboratory instrument.
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-2244-2013	Instrumentation Laboratory Co.	2	ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-2245-2013	Instrumentation Laboratory Co.	2	ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-2246-2013	Instrumentation Laboratory Co.	2	ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-2247-2013	Instrumentation Laboratory Co.	2	ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-2248-2013	Instrumentation Laboratory Co.	2	ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-2249-2013	Instrumentation Laboratory Co.	2	ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-2250-2013	Instrumentation Laboratory Co.	2	ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-2387-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-2388-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-2389-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-2390-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-2391-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-2392-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

Similar Registrations

Registration Number	Establishment Name	Location
2518152	CHRONO-LOG CORP.	HAVERTOWN, PA, US
3002721930	Accriva Diagnostics, Inc.	San Diego, CA, US
3005269352	Invetech Pty Ltd	Mount Waverley Victoria, AU
3016571810	ZACROS CORPORATION MIE FACILITY	NABARI CITY Mie, JP
9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1217183. Last updated year: 2026. Please use registration number 1217183 when referencing this establishment in official correspondence.