TOTAL AND DIRECT BILIRUBIN Sulfanilic Acid Method - India CDSCO Medical Device Registration

TOTAL AND DIRECT BILIRUBIN Sulfanilic Acid Method is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000051_e30b83f492a48a25972df109b3f38c38_36109aa7792b776c979c821cf9b646c3. This device is marketed under the brand name BIOLABO ACID CALCIUM Arsenazo III Method. The license holder is Wheecon Instruments Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

TOTAL AND DIRECT BILIRUBIN Sulfanilic Acid Method

UID: IMP/IVD/2023/000051_e30b83f492a48a25972df109b3f38c38_36109aa7792b776c979c821cf9b646c3

Brand Name

BIOLABO ACID CALCIUM Arsenazo III Method

License Holder

Wheecon Instruments Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

At least four distinct bilirubin species exist in the serum: Direct-reacting bilirubin (BIOLABO ACID CALCIUM Arsenazo III Method) consists of mono and diconjugated bilirubin (BIOLABO ACID CALCIUM Arsenazo III Method) and the δ-fraction which is bilirubin tightly bound to albumin; unconjugated α-bilirubin which is water soluble and bound to albumin. Total bilirubin (BIOLABO ACID CALCIUM Arsenazo III Method) is the sum of these different species. There are icteruses in which unconjugated bilirubin redominates (BIOLABO ACID CALCIUM Arsenazo III Method) ; icteruses in which conjugated bilirubin predominates (BIOLABO ACID CALCIUM Arsenazo III Method) ; finally, icteruses in which both species of bilirubin are present without any predominance (BIOLABO ACID CALCIUM Arsenazo III Method)

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IRON Bathophenanthrolin(BIOLABO IRON Bathophenanthrolin)

Brand: BIOLABO ACID CALCIUM Arsenazo III Method

Wheecon Instruments Private Limited

TOTAL AND DIRECT BILIRUBIN Sulfanilic Acid Method - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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STONE ANALYSIS SET Chemical qualitative method

URIC ACID Uricase method

UREA U.V Kinetic Method