Fabricant

Instrumentation Laboratory

États-UnisEntités : Instrumentation Laboratory Company

Marchés : Autriche · Italie · États-Unis

Autorisations : UE – classe A, B, C · États-Unis (FDA) – 510(k) : 377 · PMA : 1 · classe I, II, III · dernière en 2026 · voir sur le site de la FDA

Marchés publics remportés : Italie 36

Mandataire UE : Instrumentation Laboratory SpA (Italie)

Site web Regulatory@werfen.com

37 catégories, 278 modèles dont 278 en vente, 1 pays

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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Coagulometers - hardware accessories	W0202020180	10 mL Vial Reagent Adapter without magnetic stirring (pink), 4/package 00019076200 10 mL Vial Reagent Adapters with magnetic stirring (gray) 00018181265 10L Waste Bottle Container 00097002610 2D Bar Code Reader Upgrade Kit 00028210500 4 mL Vial Reagent Adapter without magnetic stirring (green), 6/package 00019076100 138 autres 4 mL Vial Sample Tray Adapter, 6/package 00019076300 4L CL Rinse Aspirator 00029781616 ACL TOP 300 350 CTS Filter reagent cooling fan 00027333801 ACL TOP 500 550 CTS Filter reagent cooling fan 00029528901 ACL TOP 700 750 Filter reagent cooling fan 00028617301 AcuStar, Cuvette Waste Bin 0009801030 AcuStar, Sample Rack 12/PK 0009801012 AcuStar, Sample Rack Adapters 0009801020 Adapter Set Micro Tube 00028529300 Adapter, Diluent 4mL,Rack Adapter, 2 pcs 00028526001 Adapter, Diluent, 10mL, 2 pcs 00028526101 Adapter, Diluent, 20mL, 2 pcs 00028526201 Air Filter Assay 00018181271 Aliquot Tube Adapter 10/PK 00028533400 Assy Tank for Waste 00018105769 Assy, CTS Tube Adapter 00028529400 Assy, Filter Changer, CTS 00028386300 Assy, Needle, ACL Elite/Elite Pro 00018110843 Bar Code Label Kit 00000009199 Bottle, Waste 10L 00018901300 Clean, Aspirator Assy (Tube connecting ACL TOP instrument to the Clean Bottle) 00028713200 CRU, Probe N Seal, Mini 00028660141 CTS Rack Adapter blue (48 PK) 00027500148 CTS Rack Adapter blue (96 PK) 00027500149 CTS Sarstedt Rack Set, 14 mm, 01-12 00000051601 CTS Sarstedt Rack Set, 14 mm, 13-24 00000051602 CTS Sarstedt Rack Set, 14 mm, 25-36 00000051603 CTS Sarstedt Rack Set, 14 mm, 37-48 00000051604 CTS Sarstedt Rack Set, 14 mm, 49-60 00000051605 CTS Sarstedt Rack Set, 14 mm, 61-72 00000051606 CTS Sarstedt Rack Set, 14 mm, 73-84 00000051607 CTS Sarstedt Rack Set, 14 mm, 85-96 00000051608 CTS Sarstedt Rack Set, 16.3 mm, 01-12 00000051501 CTS Sarstedt Rack Set, 16.3 mm, 13-24 00000051502 CTS Sarstedt Rack Set, 16.3 mm, 25-36 00000051503 CTS Sarstedt Rack Set, 16.3 mm, 37-48 00000051504 CTS Sarstedt Rack Set, 16.3 mm, 49-60 00000051505 CTS Sarstedt Rack Set, 16.3 mm, 61-72 00000051506 CTS Sarstedt Rack Set, 16.3 mm, 73-84 00000051507 CTS Sarstedt Rack Set, 16.3 mm, 85-96 00000051508 Diluent Rack Set, DD-DF 00029400712 Diluent Rack, Set DA - DC 00029400711 Filter, 370 Fan 00037010000 Filter, 570 Fan 00057010000 Filter, 770 Fan 00077010000 Fuses, 6.3 AT, 2/package 00006893102 Host Computer Cable (9 pin – 9 pin) 00018420238 Kit Replacement Piercing Probe CTS 00028600006 Kit Rinse Manifold, Packaged 00000011857 Kit, Adapter 10mL Vial ACL TOP 00028520901 Kit, Adapter 4mL Vial ACL TOP 00028520501 Kit, Sample Probe CTS 00029403701 Kit, TOP Status Indicator Light 00000013187 Micro Tube Adapter 10/PK 00028533700 Pediatric Tubes Adapter 10/PK 00028533500 Pump/Probe Tubing Assembly 00028741600 Rack Set, Diluent DA-DB,ACL TOP 00029400741 Rack Set, Diluent DC-DD,ACL TOP 00029400742 Reagent Rack Set, RA - RD 00029400641 Reagent Rack Set, RE - RH 00029400642 Reagent Rack, Set RA - RF 00029400601 Reagent Rack, Set RG - RM 00029400602 Rinse, Aspirator Assy, 4 L (Tube connecting ACL TOP instrument to the Rinse Bottle) 00028713400 Rotor Insertion Tool 00018181277 Rotor Waste Container 00018110897 Sample and Reagent Tubing, 1.5 meters long 00007328901 Sample Rack Adaptor – Narrow Tube (30 Pieces) 0009801025 Sample Rack Set 01-08, ACL CTS 00029400941 Sample Rack Set 01-08, ACL TOP 00029400541 Sample Rack Set 01-12, ACL CTS 00029400901 Sample Rack Set 09-16, ACL CTS 00029400942 Sample Rack Set 09-16, ACL TOP 00029400542 Sample Rack Set 13-24, ACL CTS 00029400902 Sample Rack Set 17-24, ACL CTS 00029400943 Sample Rack Set 17-24, ACL TOP 00029400543 Sample Rack Set 25-32, ACL CTS 00029400944 Sample Rack Set 25-32, ACL TOP 00029400544 Sample Rack Set 25-36, ACL CTS 00029400903 Sample Rack Set 33-40, ACL CTS 00029400945 Sample Rack Set 33-40, ACL TOP 00029400545 Sample Rack Set 37-48, ACL CTS 00029400904 Sample Rack Set 41-48, ACL CTS 00029400946 Sample Rack Set 41-48, ACL TOP 00029400546 Sample Rack Set 49-56, ACL CTS 00029400947 Sample Rack Set 49-56, ACL TOP 00029400547 Sample Rack Set 49-60, ACL CTS 00029400905 Sample Rack Set 57-64, ACL CTS 00029400948 Sample Rack Set 57-64, ACL TOP 00029400548 Sample Rack Set 61-72, ACL CTS 00029400906 Sample Rack Set 73-84, ACL CTS 00029400907 Sample Rack Set 85-96, ACL CTS 00029400908 Sample Rack, Set 01 - 12 00029400501 Sample Rack, Set 13 - 24 00029400502 Sample Rack, Set 25 - 36 00029400503 Sample Rack, Set 37 - 48 00029400504 Sample Rack, Set 49 - 60 00029400505 Sample Rack, Set 61 - 72 00029400506 Sample Rack, Set 73 - 84 00029400507 Sample Rack, Set of 85-96 00029400508 Sample Tray Adapter for Plastic Cups, 4/package 00019076400 Sample Tray, 5mL 00018110898 Sample Tube Adapter CTS 10/PK 00028533600 Sarstedt rack set 14mm 01-08, ACL CTS 00000051401 Sarstedt rack set 14mm 09-16, ACL CTS 00000051402 Sarstedt rack set 14mm 17-24, ACL CTS 00000051403 Sarstedt rack set 14mm 25-32, ACL CTS 00000051404 Sarstedt rack set 14mm 33-40, ACL CTS 00000051405 Sarstedt rack set 14mm 41-48, ACL CTS 00000051406 Sarstedt rack set 14mm 49-56, ACL CTS 00000051407 Sarstedt rack set 14mm 57-64, ACL CTS 00000051408 Sarstedt rack set 14mm 65-72, ACL CTS 00000051409 Sarstedt rack set 14mm 81-88, ACL CTS 00000051411 Sarstedt rack set 14mm 89-96, ACL CTS 00000051412 Sarstedt rack set 14mm73-80, ACL CTS 00000051410 Sarstedt rack set 16.3mm 01-08, ACL CTS 00000051301 Sarstedt rack set 16.3mm 09-16, ACL CTS 00000051302 Sarstedt rack set 16.3mm 17-24, ACL CTS 00000051303 Sarstedt rack set 16.3mm 25-32, ACL CTS 00000051304 Sarstedt rack set 16.3mm 33-40, ACL CTS 00000051305 Sarstedt rack set 16.3mm 41-48, ACL CTS 00000051306 Sarstedt rack set 16.3mm 49-56, ACL CTS 00000051307 Sarstedt rack set 16.3mm 57-64, ACL CTS 00000051308 Sarstedt rack set 16.3mm 65-72, ACL CTS 00000051309 Sarstedt rack set 16.3mm 73-80, ACL CTS 00000051310 Sarstedt rack set 16.3mm 81-88, ACL CTS 00000051311 Sarstedt rack set 16.3mm 89-96, ACL CTS 00000051312 Sarstedt Sample Tray, 11.5 mm 00018181285 Start Up, Aliquot Set 00028525100 Syringe, 1000 uL, PE, PSD4 00028753401 Syringe, 250 µL PE, PSD4 00028753201 Syringes and plunger Assy (250 uL) 00028754001 Tool, Needle Alignment, ACL Series 00018103941 Tray, 6 Sample Rack, Holder 00028780201 Upgrade Kit, Bar Code Scanner 00018112145 Waste Bottle Presence Sensor Assembly 00028771801 Waste Reservoir Package, for needles wash 00018181272 Waste Sensor Assembly 00029781767 Waste Tube, 1.5 m 00009909503	A IVDR	Fiche EUDAMED Signaler une erreur
Coagulometers - consumables	W0202020185	00006800000 ACL TOP Cuvettes 0029400100 AcuStar Cuvettes 0009801100 Bottles, Glass, 10mL, 10/package 00018924100 Bottles, Glass, 20 mL, 8/package 00019085463 23 autres Bottles, Glass, 4mL, 10/package 00018924104 Bottles, Plastic, 30 mL, (with cap) 10/pack 00018902000 CTS Filter 12 pack 00029403501 Cuvette Waste Liner 370/570, 10/package 00097004501 Cuvette Waste Liner, 10/package 00029401100 Cuvette Waste Liner, 770 10/package 00097004500 Cuvette, Waste Bin, 10/package 00027344900 HemosIL AcuStar Cleaning Solution 0009802204 HemosIL AcuStar System Rinse 0009802200 HemosIL AcuStar Triggers 0009802201 HemosIL CL Rinse Solution 00029781038 HemosIL CL Triggers 00029781030 HemosIL Cleaning Agent (Clean B) 0009832700 HemosIL Cleaning Solution (Clean A) 0009831700 HemosIL Factor Diluent 0009757600 HemosIL Probe Conditioner 0009850000 HemosIL Rinse Solution 0020302400 HemosIL Wash-R Emulsion 0020002400 Liner, Waste Bucket, 10pk 00029506900 Magnetic Stirrer Bars, 6 per package 00009746606 Sample Cups 2.0 mL, 1000/package 0005575100 Sample Cups, 0.5 mL, 1000/package 00006799200 Sample Cups, 4 mL, 100/package 00006799400	A IVDR	Fiche EUDAMED Signaler une erreur
Control plasma for haemostasis	W0103020702	HemosIL AcuStar D-Dimer Controls 0009802100 HemosIL AcuStar HIT Controls 0009802122 HemosIL AcuStar VWF Controls 0009802119 HemosIL Apixaban Controls 0020014300 HemosIL CL Multi-Ab Controls 0029704000 18 autres HemosIL D-Dimer Controls 0020013000 HemosIL D-Dimer HS 500 Controls 0020013100 HemosIL Dabigatran Controls 0020013500 HemosIL High Abnormal Control Assayed 0020003310 HemosIL Homocysteine Controls 0020007900 HemosIL INR Validate 0020010500 HemosIL LA Negative Control 0020012600 HemosIL LA Positive Control 0020012500 HemosIL LMW Heparin Controls 0020300200 HemosIL Low Abnormal Control Assayed 0020003210 HemosIL Low Fibrinogen Control 0020004200 HemosIL Normal Control Assayed 0020003110 HemosIL Plasma Coagulation Control Level I 0020010700 HemosIL Plasma Coagulation Control Level II 0020010800 HemosIL Rivaroxaban Controls 0020013700 HemosIL Special Test Control Level 1 0020011000 HemosIL Special Test Control Level 2 0020012000 HemosIL UF Heparin Controls 0020300300	B, C IVDR	Fiche EUDAMED Signaler une erreur
Automated coagulometers	W0202020102	ACL AcuStar 0009801000 ACL ELITE 00000880311 ACL ELITE PRO 00001000311 ACL ELITE Pro Refurbished 00001000311R ACL Elite Refurbished 00000880311R 11 autres ACL TOP 350 CTS 00000280065 ACL TOP 370 00000280067 ACL TOP 550 CTS 00000280045 ACL TOP 570 00000280047 ACL TOP 750 00000280015 ACL TOP 750 CTS 00000280055 ACL TOP 750 LAS 00000280035 ACL TOP 770 00000280057 ACL TOP 770 LAS 00000280037 ACL TOP 770s 00000280017 ACL TOP 970 CL 00000280097	A IVDR	Fiche EUDAMED Signaler une erreur
Calibration plasma for haemostasis	W0103020701	HemosIL Apixaban Calibrators 0020014200 HemosIL Calibration Plasma 0020003700 HemosIL Dabigatran Calibrators 0020013400 HemosIL Heparin Calibrators 0020300600 HemosIL ISI Calibrate 0020010600 1 autre HemosIL Rivaroxaban Calibrators 0020013600	C IVDR	Fiche EUDAMED Signaler une erreur
BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)	W0201040102	GEM Premier 3500 (Refurbished) 00026000000R GEM Premier 3500 00026000000 GEM Premier 5000 00024019255 GEM Premier 7000 with iQM3 00000015279 GEM Premier ChemSTAT 00044000000	A IVDR	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	HemosIL AcuStar D-Dimer 0009802000 HemosIL D-Dimer 0020008500 HemosIL D-Dimer 500 0020301000 HemosIL D-Dimer HS 0020007700 HemosIL D-Dimer HS 500 0020500100	C IVDR	Fiche EUDAMED Signaler une erreur
Antithrombin	W0103020602	HemosIL Liquid Antithrombin 0020002500 HemosIL Liquid Antithrombin 0020030100 HemosIL Liquid Antithrombin 0020300400 HemosIL Liquid Antithrombin 0020300440	B IVDR	Fiche EUDAMED Signaler une erreur
Fibrinogen assays (factor i)	W0103020201	HemosIL Fibrinogen-C 0020301100 HemosIL Fibrinogen-C XL 0020003900 HemosIL Q.F.A. Thrombin (Bovine) 0020301700 HemosIL Q.F.A. Thrombin (Bovine) 0020301800	B IVDR	Fiche EUDAMED Signaler une erreur
Prothrombin time ( quick test )	W0103020101	HemosIL PT-Fibrinogen HS PLUS 0008469810 HemosIL ReadiPlasTin 0020301400 HemosIL RecombiPlasTin 2G (20 mL) 0020003050 HemosIL RecombiPlasTin 2G (8 mL) 0020002950	C IVDR	Fiche EUDAMED Signaler une erreur
Activated partial thromboplastin time	W0103020102	HemosIL APTT-SP 0020006300 HemosIL SynthAFax 0020007400 HemosIL SynthASil 0020006800	C IVDR	Fiche EUDAMED Signaler une erreur
Blood gas analysers - hardware accessories	W0201040180	2D BARCODE GUN 00025000420 Corded 2D Barcode Imager 00024015859 Wireless Barcode Scanner, 2D 00025000400	A IVDR	Fiche EUDAMED Signaler une erreur
Lupus anticoagulant	W0103020606	HemosIL dRVVT Confirm 0020301600 HemosIL dRVVT Screen 0020301500 HemosIL Silica Clotting Time 0020004800	B IVDR	Fiche EUDAMED Signaler une erreur
Protein c	W0103020607	HemosIL ProClot 0008468310 HemosIL ProClot diluent 0008468600 HemosIL Protein C 0020300500	A, B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor ix	W0103020208	HemosIL Chromogenic Factor IX 0020001900 HemosIL Factor IX deficient plasma 0020011900	C IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor viii	W0103020207	HemosIL Factor VIII deficient plasma 0020011800 HemosIL Factor VIII deficient plasma 0020012800	C IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor von willebrand (ag)	W0103020215	HemosIL AcuStar VWF:Ag 0009802020 HemosIL von Willebrand Factor Antigen 0020002300	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor von willebrand activity / ristocetin cofactor activity (rco)	W0103020217	HemosIL AcuStar VWF:RCo 0009802024 HemosIL von Willebrand Factor Activity 0020004700	B IVDR	Fiche EUDAMED Signaler une erreur
Platelet factor 4	W0103020402	HemosIL AcuStar HIT-IgG(PF4-H) 0009802028 HemosIL CL HIT-IgG(PF4-H) 0029706200	B IVDR	Fiche EUDAMED Signaler une erreur
A2-antiplasmin	W0103020501	HemosIL Plasmin Inhibitor 0020009200	B IVDR	Fiche EUDAMED Signaler une erreur
Adamts13 (activity, ag, ab, inhibitor) specific von willebrand factor (vwf) - cleaving protease	W0103020311	HemosIL AcuStar ADAMTS13 Activity 0009802048	B IVDR	Fiche EUDAMED Signaler une erreur
Anti iia activity fot doac	W0103020310	HemosIL Direct Thrombin Inhibitor Assay 0020302800	C IVDR	Fiche EUDAMED Signaler une erreur
Anti xa activity for heparin and doac	W0103020309	HemosIL Liquid Anti-Xa 00020302601	C IVDR	Fiche EUDAMED Signaler une erreur
Apc resistance	W0103020610	HemosIL Factor V Leiden (APC Resistance V) 0020008700	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor II ( prothrombin )	W0103020202	HemosIL Factor II deficient plasma 0020012200	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor v	W0103020204	HemosIL Factor V deficient plasma 0020011500	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor vii	W0103020205	HemosIL Factor VII deficient plasma 0020011700	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor X	W0103020209	HemosIL Factor X deficient plasma 0020010000	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor xi	W0103020210	HemosIL Factor XI deficient plasma 0020011300	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor xii	W0103020211	HemosIL Factor XII deficient plasma 0020011200	B IVDR	Fiche EUDAMED Signaler une erreur
Coagulation factor xiii	W0103020213	HemosIL Factor XIII Antigen 0020201300	B IVDR	Fiche EUDAMED Signaler une erreur
Free protein s antigen	W0103020612	HemosIL Free Protein S 0020002700	B IVDR	Fiche EUDAMED Signaler une erreur
Homocysteine	W0103020614	HemosIL Homocysteine 0020007800	B IVDR	Fiche EUDAMED Signaler une erreur
Plasminogen	W0103020505	HemosIL Plasminogen 0020009000	B IVDR	Fiche EUDAMED Signaler une erreur
Protein s activity	W0103020608	HemosIL Protein S Activity 0020302000	B IVDR	Fiche EUDAMED Signaler une erreur
Standard heparin	W0103020303	HemosIL Heparin 0020009400	C IVDR	Fiche EUDAMED Signaler une erreur
Thrombin time / reptilase / batroxobin time	W0103020103	HemosIL Thrombin Time 0009758515	C IVDR	Fiche EUDAMED Signaler une erreur

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