LAURA XL - India CDSCO Medical Device Registration

LAURA XL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000101_3a4185b1cf679ba13080b249d79ab64c_606a69a653988476d9e6e48bbdb1a5df. 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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CDSCO Registered

Class Class A

LAURA XL

UID: MFG/IVD/2023/000101_3a4185b1cf679ba13080b249d79ab64c_606a69a653988476d9e6e48bbdb1a5df

Brand Name

Erba

License Holder

Transasia Bio-Medicals Limited

Device Class

Class A

Approving Authority

Greater Mumbai Division

Product Information

The fully automated Urine Analyzer, hybrid system combining urine test strip chemistry and urine microscopy, producing microscopic images of urine sediment and automatically classifying and counting urine sediment particles from the images together in a single integrated device. The test strip chemistry module is intended for the in vitro measurement of: specific gravity, leukocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood, ascorbic acid, microalbumine and creatinine, plus color and turbidity. The chemistry module is intended for use with the multi-parameter urine chemistry test strips - PHAN® Auto.

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Hb-Vario

Brand: Erba

Transasia Bio-Medicals Limited

LAURA XL - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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Fully Automated Immunoassay Analyzer Lisa XL

Semi Automated Biochemistry Analyzer