Manufacturer

Spectrum For Diagnostic Industries Joint Stock

EgyptLegal entities : Spectrum for Diagnostic Industries (Joint Stock Company)

First countries of placing on the market declared in EUDAMED : Germany

EU representative : MDSS GmbH (Germany)

15 categories, 37 models including 37 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
Brucella	W0105011701	Brucella A/M5 refs98/79 Brucella Abortus98/79 Brucella Combo2 refs98/79 Brucella Melitensis98/79 Brucella Rose Bengal98/79 1 other Rose Bengal Brucella Antigen4 refs98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood)98/79 H. pylori Ab Test98/79 H. pylori Ag Rapid Test Cassette (Fecal Specimen)98/79 H. pylori Ag Test98/79	– 98/79	EUDAMED record Report an error
Haemoglobin determinations (total hb)	W0103010201	Haemoglobin (Ready To Use)3 refs98/79 Haemoglobin (Single Reagent)2 refs98/79 Haemoglobin Drabkin's Solution2 refs98/79 Hemoglobin (Ready-To-Use)Drabkin’s Solution2 refs98/79	– 98/79	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	PT Reagent (SP-Normoplastin)2 refs98/79 PT Reagent ISI 1.052 refs98/79 PT Reagent ISI 1.52 refs98/79 Recoplastin ISI 1.0 PT Reagent4 refs98/79	– 98/79	EUDAMED record Report an error
Cellular enzyme determination reagents (g-6-pdh, pyruvate kinase)	W0103019001	G6PD98/79 G6PD - single reagent98/79 Glucose-6-Phosphate dehydrogenase (G-6-PD)98/79	– 98/79	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	FIBRINOGEN98/79 FIBRINOGEN Immuno - Turbidimetry98/79 FIBRINOGEN-LS Clauss Clotting Time Method2 refs98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Typhoid IgG/IgM Rapid Test-Cassette98/79 Typhoid Rapid Test Cassette (Serum/Plasma/Whole Blood)98/79 Widal Test (Salmonella Ab)13 refs98/79	– 98/79	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	APTT Reagent98/79 APTT Reagent (SP-UNICELIN)2 refs98/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	"S.typhi-S.paratyphi "A Direct Antigen Detection98/79 S. Typhi/Para Typhi A Antigen2 refs98/79	– 98/79	EUDAMED record Report an error
Cmv - RT & POC	W0105099001	CMV IgG/IgM Rapid Test-Cassette98/79	– 98/79	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	Plasma control set For coagulation Assays98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Turbi Latex7 refs98/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	HAV IgM Rapid Test Cassette (Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria Antigen Test Card2 refs98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	RPR Syphilis Test4 refs98/79	– 98/79	EUDAMED record Report an error

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