Manufacturer

Fortress Diagnostics

Northern IrelandLegal entities : Fortress Diagnostics Ltd

Markets : Northern Ireland

22 categories, 87 models including 87 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	CELLCLEAN AUTO HAEM042G98/79 Celldiff Diluent HAEM09198/79 Celldiff Fluorescent Dye HAEM510A98/79 Celldiff LD-5 lyse HAEM510B98/79 Celldiff LH-5 Lyse HAEM510C98/79 25 others CELLDIFF+ CLEAN HAEM042A98/79 CELLDIFF+ CLEAN HAEM042B98/79 CELLDIFF+ CLEAN HAEM042C98/79 CELLDIFF+ DILUENT HAEM034A98/79 CELLDIFF+ ENHANCED CLEANER HAEM033A98/79 Celldiff-560 CELLD56098/79 CLEANER NK HAEM09398/79 Diluent Concentrate - Powder HAEM034Q98/79 DILUENT MR HAEM66MR98/79 DILUENT NK HAEM66NK98/79 DILUENT ST HAEM66ST98/79 Diluent/Sheath HAEM67DA98/79 DYE-WDF HAEM035C98/79 DYE-WNR HAEM035B98/79 HAEM09298/79 HGB/NOC Lyse HAEM67HA98/79 LYSE-4DL HAEM043D98/79 LYSE-4DS HAEM043C98/79 LYSE-FBA HAEM043B98/79 LYSE-SWH HAEM043W98/79 LYSER-SLS HAEM043O98/79 LYSER-WDF HAEM043Q98/79 LYSER-WNR HAEM043P98/79 Urine Cleanser URSAUC0198/79 WBC Lyse HAEM67WA98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Salmonella AH FEBSAF1L98/79 Salmonella BH FEBSBH1L98/79 Salmonella O, Salmonella H + Positive Control FEBSOH0598/79 Salmonella paratyphi A-H FEBAH35798/79 Salmonella paratyphi A-H FEBSAH0598/79 14 others Salmonella paratyphi A-H FEBSAH35798/79 Salmonella paratyphi A-O FEBSAO35798/79 Salmonella paratyphi B-H FEBBH35798/79 Salmonella paratyphi B-H FEBSBH0598/79 Salmonella paratyphi B-H FEBSBH35798/79 Salmonella paratyphi B-O FEBSBO0598/79 Salmonella paratyphi C-H FEBSCH0598/79 Salmonella paratyphi C-O FEBSCO0598/79 Salmonella Typhi H (Trays) FEBTH35798/79 Salmonella typhi H FEBSTH0598/79 Salmonella typhi H FEBSTH1L98/79 Salmonella Typhi O (Trays) FEBTO35798/79 Salmonella typhi O FEBSTO0598/79 Salmonella typhi O FEBSTO1L98/79	– 98/79	EUDAMED record Report an error
Immunohaematology (blood grouping) tests - other	W01030399	Fortress Crossmatch Patient BGGCFCT1-5098/79 Fortress LISS Diluent BGGCL50098/79 Low Ionic Strength Solution BGLS101098/79 Serological Albumin 22% BG22022198/79 Serological Albumin 22% BG22101098/79 1 other Serological Albumin 22% BGAL221098/79	– 98/79	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	D-Dimer Control (Level I) COAG134A98/79 D-Dimer Control (Level II) COAG135A98/79 Plasma Control Level I & II (COAG112A)98/79 Plasma Control Level I COAG108A98/79 Plasma Control Level II COAG109A98/79	– 98/79	EUDAMED record Report an error
Abnormal blood controls	W0103010502	Haematology Control (Level 1) HAEMC00198/79 Haematology Control (Level 3) HAEMC00398/79 Haematology Control L2, 9 Parameter CHEMA3L298/79	– 98/79	EUDAMED record Report an error
Normal blood controls	W0103010501	Haematology Control (Level 2) HAEMC00298/79 HAEMATOLOGY CONTROL LOW HAEM003L98/79 Haematology Control Normal HAEMC00Z98/79	– 98/79	EUDAMED record Report an error
Streptococcal reagents - other	W0105011199	ASO Latex (Reagent) LXASO00598/79 ASO Latex Kit LXASO05098/79 ASO Latex Kit LXASO15098/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Latex Kit COAG115D98/79 D-Dimer Latex Kit COAG115E98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H.Pylori Device (WB/S/P) HPYC002098/79 Helicobacter Pylori Test Strip (Serum/Plasma) HPS0005098/79	– 98/79	EUDAMED record Report an error
Whole blood calibrators	W0103010507	Haematology Calibrator HAEMC00598/79 HbA2 Calibrator Set (Normal & Abnormal) BXC0664A98/79	– 98/79	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	APTT Reagent with Calcium Chloride (Liquid Stable) COAG110A98/79	– 98/79	EUDAMED record Report an error
Antibody 3 cell screening	W0103030308	Fortress Cell Screen 1-2-3 BGGCS12398/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - hardware accessories	W0201020180	Innowash Microplate Washer Display Assembly FORTMWI298/79	– 98/79	EUDAMED record Report an error
Brucella	W0105011701	Rose Bengal FEBRB01L98/79	– 98/79	EUDAMED record Report an error
Coagulation factor v	W0103020204	FACTOR V Assay Kit COAG128B98/79	– 98/79	EUDAMED record Report an error
Coagulation factor xi	W0103020210	FACTOR XI Assay Kit COAG133B98/79	– 98/79	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	Fibrinogen (L.S) Immunoturbidimetric, Multipoint BXC0442A98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H.Pylori Device (WB/S/P) HPYC004098/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Helicobacter Pylori, IgM ELISA BXE0674A98/79	– 98/79	EUDAMED record Report an error
Multilevel blood controls	W0103010503	Haematology Control (3 Levels - 3x3x3ml) HAEMC00498/79	– 98/79	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	PT High Sensitivity (Liquid Stable) ISI ~1.15 COAG101C98/79	– 98/79	EUDAMED record Report an error
Rickettsia	W0105011705	Proteus OXK FEPOXK0598/79	– 98/79	EUDAMED record Report an error

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