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Semi Auto Biochemistry Analyzer - India CDSCO Medical Device Registration

Semi Auto Biochemistry Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000502_1863df216831838e4951731739b2e938_5aa1b1fc915b7751228d1e647a3f39ec. This device is marketed under the brand name Elitech. The license holder is Q-Line Biotech Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered
Class Class A
Semi Auto Biochemistry Analyzer
UID: IMP/IVD/2022/000502_1863df216831838e4951731739b2e938_5aa1b1fc915b7751228d1e647a3f39ec

Brand Name

Elitech

Device Class

Class A

Approving Authority

CDSCO

Product Information

The analyzer is an semi-automated chemistry analyzer, to be used in combination with certain reagents for in vitro diagnostic measurement of analytes in samples of serum, plasma, urine and aqueous standard solutions. The analyzer is designed as an ยดopenยด system. Most clinical chemistry tests that require a photometric measurement can be adapted for the system. The analyzer is intended for use in clinical chemistry laboratories where the workload is of low quantity. The analyzer must be operated by qualified and trained personnel.

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