Development and production of lateral flow rapid tests, ELISA kits and diagnostic reagents for human and veterinary diagnostics.
Arvin BioHealth (Arvin Zist Salamat)
IranNew on Amplifa
About Arvin BioHealth
Arvin BioHealth (Persian: Arvin Zist Salamat) is a knowledge-based company founded in 2015 (1395 in the Iranian calendar) as a subsidiary of the Arvin Pazhoohan Noor (APN) Holding by university lecturers and research centers. The company researches, develops, manufactures and distributes in vitro diagnostics, including lateral flow rapid tests (including SARS-CoV-2 antigen, IgG/IgM and neutralizing antibody tests, pregnancy tests, drug tests, cardiac troponin I, FOB), ELISA kits and diagnostic reagents. In addition, raw materials for the vaccine industry and biotechnology products are manufactured. Production is carried out in accordance with EN ISO 13485:2016 with cleanrooms and modern production infrastructure. In 2023, as the first manufacturer in Iran, production of rapid tests for pet diseases was launched with approval from the Veterinary Organization. The products are used in hospitals, clinical laboratories, medical practices, veterinary clinics as well as for home use for screening, prognosis, diagnosis and therapy monitoring purposes. The company's own R&D team develops custom assays and manufactures prototypes according to customers' ideas.
- Site
- Iran
- Processes
- Manufacture of rapid diagnostic tests (immunochromatography/lateral flow), Manufacture of ELISA kits, Manufacture of diagnostic reagents, Manufacture of raw materials for the vaccine industry and biotechnology products, R&D: development of lateral flow and ELISA assays, prototype development, Production in accordance with EN ISO 13485:2016 with cleanrooms, Research & Development (R&D, lateral flow and ELISA assays), Production of rapid diagnostic kits
- Materials
- Immunochromatography / Lateral Flow, ELISA (Enzyme-linked Immunosorbent Assay), Diagnostic reagents, Raw materials for the vaccine industry and biotechnology
- Certificates
- EN ISO 13485:2016
- Founded
- 2015 (1395
- Industries
- Medical technology/IVD, Veterinary diagnostics, Vaccine industry, Biotechnology, Agriculture, Medical technology/IVD (in vitro diagnostics)
- 01
Research & Development (Lateral Flow, ELISA, prototypes)
- 02
Raw material production
- 03
Manufacture of rapid diagnostic kits and ELISA kits
- 04
Reagent production
- 05
Quality control in accordance with EN ISO 13485:2016
- 06
Sales and distribution
Product Areas and Processes
Immunochromatography / Lateral Flow
Rapid tests for antigen, antibody and drug detection in serum, plasma, whole blood and urine.
ELISA (Enzyme-linked Immunosorbent Assay)
Laboratory diagnostic kits for quantitative detection in clinical laboratories.
Diagnostic reagents
Reagents for clinical diagnostics.
Raw materials for the vaccine industry and biotechnology
Production of starting materials for vaccines and biotechnology products.
Location
Iran
DEManufacturing, R&D and sales
- Materials
- Lateral Flow, ELISA, reagents
- Production machines for IVD products
- Cleanrooms
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture of rapid diagnostic tests (immunochromatography/lateral flow)Testing | – | – | – | – | – |
| Manufacture of ELISA kitsTesting | – | – | – | – | – |
| Manufacture of diagnostic reagentsTesting | – | – | – | – | – |
| Manufacture of raw materials for the vaccine industry and biotechnology productsEngineering | – | – | – | – | – |
| R&D: development of lateral flow and ELISA assays, prototype developmentEngineering | – | – | – | – | – |
| Production in accordance with EN ISO 13485:2016 with cleanroomsTesting | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Production machines for IVD products (not specified) | – | – | – | – | Iran |
| Cleanrooms | – | – | – | – | Iran |
Additional services
Quality
Production is carried out in accordance with the EN ISO 13485:2016 quality management system for medical devices with cleanrooms, experienced technical personnel and its own quality assurance (headed by Dr. Ahmadi).
| Evidence | Iran |
|---|---|
| EN ISO 13485:2016 |
History
- 2015
Founded as a knowledge-based company under the Arvin Pazhoohan Noor (APN) Holding by university members and research centers; recognized by governmental science and innovation organizations.
- 2020
Development and production of SARS-CoV-2 rapid tests (IgG/IgM, neutralizing antibody, antigen) for rapid diagnosis during the corona epidemic in Iran; presented in the TV program 'Nowavaran' on Iranian state television.
- 2023
First production of rapid tests for pet diseases in Iran with approval from the Veterinary Organization.