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Egyptian Company For Biotechnology-Spectrum Diagnostics

Egypt·EG-MF-000032599

Last updated September 18, 2026

About

Egyptian Company for Biotechnology-Spectrum diagnostics designs , develops and manufactures high quality in vitro diagnostic reagents. We are actively involved in state-of-the art research and development initiatives designed to keep our customers at the forefront of diagnostic technology. During the 2000s our research team initiated an aggressive research and development program, which resulted in the development of a new generation of liquid stable clinical chemistry reagents using the Micro Stab technology. In-addition, we developed a line of dedicated portable photometers.

From the manufacturer's own website. Source

What Egyptian Company For Biotechnology-Spectrum Diagnostics makes

The company produces in vitro diagnostic (IVD) reagents and media, including copper bioreagents, blood culture media, and enzymatic assays for clinical chemistry parameters such as alkaline phosphatase (ALP), calcium, bilirubin, and ammonia. It also manufactures immunodiagnostic reagents like antistreptolysin O (ASO) and troponin-I, as well as portable photometer-compatible test kits for urine analysis (Uritrak).

These products fall under EU IVD device classifications, including Class A and Class B reagents, as well as IVD General category devices. The manufacturer’s reagents are registered in the EU’s eudamed database, and the company is based in Egypt.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Egypt
Address: Obour City industrial area Block 20008 , Cairo , Egypt
Website: www.spectrum-diagnostics.com
LinkedIn: —
Facebook: facebook.com/SpectrumDiagnostics
Email: [email protected]
Phone: +202244892248
PRRC Contact: Ahmed Alyan
EUDAMED SRN: EG-MF-000032599
FDA FEI Number: —
DUNS Number: —

Catalogue (245)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Lactate dehydrogenase (LDH) – liquizyme (4+1)	283 001	EUDAMED	IVD General	Active
Uritrak - 1, 2, 3, 5 and 10	1100 100	EUDAMED	IVD General	Active
Triple Sugar Iron Agar	1422 001	EUDAMED	Class A	Active
Rheumatoid Factor (RF)	518 003	EUDAMED	IVD General	Active
Aspartate aminotransferase (AST/GOT) – single reagent	261 004	EUDAMED	IVD General	Active
Immunology Control Low	606 002	EUDAMED	IVD General	Active
Creatinine-Colorimetric	235 003	EUDAMED	IVD General	Active
Salmonella Shigella Agar (SS Agar)	1413 002	EUDAMED	Class A	Active
APTT Reagent (SP-UNICELIN)	626 001	EUDAMED	IVD General	Active
Sodium - single reagent	303 002	EUDAMED	IVD General	Active
Widal Test (Salmonella Ab)	718 003	EUDAMED	IVD General	Active
Blood Culture Medium	1452 008	EUDAMED	Class A	Active
Blood Culture Medium	1452 002	EUDAMED	Class A	Active
Ferritin Turbi Latex	562 001	EUDAMED	IVD General	Active
Widal Test (Salmonella Ab)	718 001	EUDAMED	IVD General	Active
Salmonella Shigella Agar (SS Agar)	1413 001	EUDAMED	Class A	Active
Carbon Dioxide (CO2) (Colorimetric PEPC)	228 001	EUDAMED	IVD General	Active
Total Protein (Single Reagent)	310 005	EUDAMED	IVD General	Active
Triglycerides – Liquizyme GPO-PAP (Single Reagent)	314 006	EUDAMED	IVD General	Active
Alkaline Phosphatase (ALP) -Colorimetric	216 001	EUDAMED	IVD General	Active
Alanine aminotransferase (ALT/GPT) - single reagent	265003	EUDAMED	IVD General	Active
Urea/BUN – Liquizyme (UV)	319 005	EUDAMED	IVD General	Active
Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1)	292 004	EUDAMED	IVD General	Active
Alanine aminotransferase (ALT/GPT) – Liquizyme (1+1)	263 002	EUDAMED	IVD General	Active
Lipase w. Calibrator (DGMRE)	281 001	EUDAMED	IVD General	Active
Creatine Kinase (CK)	238 004	EUDAMED	IVD General	Active
Urea/BUN – single reagent	320 003	EUDAMED	IVD General	Active
Copper - Single reagent	232 002	EUDAMED	IVD General	Active
γ - Glutamyltransferase (GGT) – Liquizyme (1+1)	247 002	EUDAMED	IVD General	Active
D-Dimer Turbi Latex	585 002-1	EUDAMED	IVD General	Active
Uric acid - Liquizyme Uricase-PAP (Single Reagent)	323 003	EUDAMED	IVD General	Active
Cholinesterase DGKC	418 002	EUDAMED	IVD General	Active
HCG One Step pregnancy Test	1176 002	EUDAMED	IVD General	Active
Total Protein (Single Reagent)	310 002	EUDAMED	IVD General	Active
Alkaline Phosphatase (ALP)- Liquizyme (single reagent)	217 002	EUDAMED	IVD General	Active
Hemoglobin A1c(HbA1c) Turbidimetric Immunoassay	602 000-I	EUDAMED	IVD General	Active
Total Iron chromazurol B (Single Reagent)	269 001	EUDAMED	IVD General	Active
S. Typhi/Para Typhi A Antigen	1154 002	EUDAMED	IVD General	Active
Alkaline Phosphatase (ALP) -Liquizyme (9+1) IFCC	214 002	EUDAMED	IVD General	Active
Lactate dehydrogenase (LDH) – liquizyme (4+1)	283 003	EUDAMED	IVD General	Active
Creatinine-Jaffe	234 001	EUDAMED	IVD General	Active
HCG One Step pregnancy Test	1176 001	EUDAMED	IVD General	Active
Albumin	211 001	EUDAMED	IVD General	Active
Aspartate aminotransferase (AST/GOT) – single reagent	261 006	EUDAMED	IVD General	Active
Total Protein (Single Reagent)	310 004	EUDAMED	IVD General	Active
Hemoglobin A1c(HbA1c) Turbidimetric Immunoassay	602 001-I	EUDAMED	IVD General	Active
Nutrient Broth	1421 002	EUDAMED	Class A	Active
Albumin - BCG	211 003	EUDAMED	IVD General	Active
Albumin - BCG	211 002	EUDAMED	IVD General	Active
C Reactive Protein (CRP) (Latex)	514 003	EUDAMED	IVD General	Active

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