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Wiener Laboratorios SAIC

Argentina AR-MF-000023605 Last updated 21 Oct 2026

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Devices
76
Registries
EUDAMEDFDA 510(k)
FDA recalls
0

Catalogue76

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Authorised representatives

About

We are the largest in vitro diagnostic industry in Latin America and our product portfolio has a wide range of comprehensive solutions for laboratorios of clinical analysis of various sizes.

Translated from the manufacturer's own website. Source

What Wiener Laboratorios SAIC makes

Wiener Laboratorios SAIC produces in vitro diagnostic (IVD) reagents and consumables for coagulation testing, including coagulation control products, chromogenic substrates like Chrom ATIII, and automated testing modules such as the CMD 80 Detergent and CM 160i. The company also manufactures urine analysis strips (WIENER LAB. URINE STRIP 10 AND 11), buffers like Imidazole, and cleaning solutions for laboratory equipment, such as the WL 19 E-Z Cleanser AA and Acid Solution. Additional products include APTTest reagents for activated partial thromboplastin time (APTT) testing and specialized modules like the CMD 600 Reagent Module LT.

Wiener Laboratorios SAIC’s diagnostic devices are classified under Class A and Class II regulations, with some falling under the broader IVD General category. These products are listed in the EU’s eudamed registry and have undergone 510(k) clearance through the FDA. The company is based in Argentina.

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

Information

Country
Argentina
Address
2944, Riobamba , Rosario, Argentina
Phone
+54 341 432 9191
PRRC contact
Viviana Cetola
EUDAMED SRN
AR-MF-000023605