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Fully Automated Immunoassay Analyzer Elan 30s - India CDSCO Medical Device Registration

Fully Automated Immunoassay Analyzer Elan 30s is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000101_eba639b8e1bc88c319568ccc922a336a_49530b274e20ce33e03f7bbc32398bdf. This device is marketed under the brand name Erba. The license holder is Transasia Bio-Medicals Limited, and it is classified as Device Class Class A. The approving authority is Greater Mumbai Division.

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Class Class A
Fully Automated Immunoassay Analyzer Elan 30s
UID: MFG/IVD/2023/000101_eba639b8e1bc88c319568ccc922a336a_49530b274e20ce33e03f7bbc32398bdf

Brand Name

Erba

Device Class

Class A

Approving Authority

Greater Mumbai Division

Product Information

Automatic analyzer intended for in vitro photometric quantification of immunoassay parameters in serum and plasma. The results for tested immunoassay parameters can be used for screening, monitoring, and diagnosis. The function is specifically dependent on each assay and is described in IFU of every reagent kit provided by ERBA. For professional use in clinical laboratory only

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