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SFRI Reagent Pack for ISE 6000 - India CDSCO Medical Device Registration

SFRI Reagent Pack for ISE 6000 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000287_df0946a7bafbb6e3080ea0ff30cd8561_5aa609d91b5f3a4bf4a8c9ffd0251a5b. This device is marketed under the brand name Na+, K+,Cl-,Ca++, pH. The license holder is Edif Medical Systems, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
SFRI Reagent Pack for ISE 6000
UID: IMP/IVD/2019/000287_df0946a7bafbb6e3080ea0ff30cd8561_5aa609d91b5f3a4bf4a8c9ffd0251a5b

Brand Name

Na+, K+,Cl-,Ca++, pH

License Holder

Edif Medical Systems

Device Class

Class B

Approving Authority

CDSCO

Product Information

Solutions used to dose sodium, potassium, chloride and calcium in serum samples with SFRI ISE 6000. This analyzer also permits to determine the blood pH and the total concentration of carbon dioxide (Na+, K+,Cl-,Ca++, pH)

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