Manufacturer

Erba

CzechiaLegal entities : Erba Lachema s.r.o.

Markets : Czechia

Approvals : EU – class A, B

24 categories, 59 models including 59 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	ELite H Clean ELite H580 Dil ELite H580 Lyse13 refs Erba H360 Dil Erba H360 Lyse 8 others Erba H560 Dil Erba H560 Lyse12 refs Erba H7100 Clean 10x4 mL2 refs Erba H7100 Dil Erba H7100 Dil Ret (1 L)2 refs Erba H7100 Fluro Diff (22 mL)2 refs Erba H7100 Fluro Ret (12 mL)3 refs Erba H7100 Lyse 1 (1000 mL)3 refs	A IVDR	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	Erba Protime 2098/79 Erba Protime 4098/79 Erba Protime LS 1098/79 Erba Protime LS 10098/79 Erba Protime LS 5098/79	– 98/79	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	XL -180 with ISE2 refs XL-1000 with ISE2 refs XL-200 NEO with ISE3 refs XL-640 with ISE2 refs	A IVDR	EUDAMED record Report an error
Normal blood controls	W0103010501	ELite H5 CON3 refs Erba H3 CON3 refs Erba H7 CON3 refs Erba H7 ret CON3 refs	B IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	ELite 580 H560 H7100	B IVDR	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	Erba Control N98/79 Erba Control P98/79 Erba DDimer Control N+P98/79	– 98/79	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	Erba Actime 3098/79 Erba Actime 5098/79	– 98/79	EUDAMED record Report an error
Automated coagulometers	W0202020102	ECL 760 VERTEX CA	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	APEX IA VERTEX IA	A IVDR	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	Erba PT - INR Multical98/79 Erba Standard Plasma98/79	– 98/79	EUDAMED record Report an error
Chemistry instruments - other	W02010199	Chem 5 v3 CHEM-7	A IVDR	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	Erba Thrombin Reagent 1098/79 Erba Thrombin Reagent 2098/79	– 98/79	EUDAMED record Report an error
Haemostasis reagents - other	W01030299	Erba Clean I Erba Owrens Veronal Buffer	A IVDR	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	ECL 105 ECL 412	A IVDR	EUDAMED record Report an error
Urine strip readers	W020101020101	LAURA LAURA SMART	A IVDR	EUDAMED record Report an error
Antibiotic susceptibility analysers - hardware accessories	W0203010180	Erba Scan	A IVDR	EUDAMED record Report an error
Antibiotic susceptibility analysers - software accessories	W0203010182	ErbaExpert98/79	– 98/79	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	H360	B IVDR	EUDAMED record Report an error
Automated urine analysers	W020101020103	LAURA XL	B IVDR	EUDAMED record Report an error
Calcium chloride	W0103020901	Erba Calcium Chloride98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	Erba DDimer R 6098/79	– 98/79	EUDAMED record Report an error
Ion selective electrolyte analysers	W0201040201	EC 90	A IVDR	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	Erba Thrombin Time 2098/79	– 98/79	EUDAMED record Report an error
Whole blood calibrators	W0103010507	ELite H CAL	B IVDR	EUDAMED record Report an error

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