Pancreatic Amylase CC FS--Diagnostic reagent for quantitative in vitro determination of pancreatic amylase in serum or plasma on Sysmex BX-Series. - India CDSCO Medical Device Registration

Pancreatic Amylase CC FS--Diagnostic reagent for quantitative in vitro determination of pancreatic amylase in serum or plasma on Sysmex BX-Series. is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000379_dcadb5a097ce5292dc6ba6030e002a9a_d1c0c471cefd9a5bb3e5a61927814c13. This device is marketed under the brand name Bilirubin Auto Total FS. The license holder is Sysmex India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Pancreatic Amylase CC FS--Diagnostic reagent for quantitative in vitro determination of pancreatic amylase in serum or plasma on Sysmex BX-Series.

UID: IMP/IVD/2019/000379_dcadb5a097ce5292dc6ba6030e002a9a_d1c0c471cefd9a5bb3e5a61927814c13

Brand Name

Bilirubin Auto Total FS

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diagnostic reagent for quantitative in vitro determination of pancreatic amylase in serum or plasma on BioMajesty JCA-BM6010/C

DJ Fang

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LDL-C Select FS--Diagnostic reagent for quantitative in vitro determination of low density lipoprotein cholesterol in serum or plasma on Sysmex BX-Series.

Brand: Bilirubin Auto Total FS

Sysmex India Pvt. Ltd.

Pancreatic Amylase CC FS--Diagnostic reagent for quantitative in vitro determination of pancreatic amylase in serum or plasma on Sysmex BX-Series. - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

LDL-C Select FS--Diagnostic reagent for quantitative in vitro determination of low density lipoprotein cholesterol in serum or plasma on Sysmex BX-Series.

Cholesterol FS--Diagnostic reagent for quantitative in vitro determination of cholesterol in serum or plasma on Sysmex BX-Series.

Phosphate FS--Diagnostic reagent for quantitative in vitro determination of phosphorus in serum or plasma on Sysmex BX-Series.

TruLab HbA1 c net Level 1, TruLab HbA1 c net Level 2

LDL-c direct FS

CK-MB FS--Diagnostic reagent for quantitative in vitro determination of CK-MB in serum or plasma on Sysmex BX-Series.

HbA1 c net FS

Urea FS--Diagnostic reagent for quantitative in vitro determination of urea in serum, plasma or urine on Sysmex BX-Series.

Bilirubin Auto Total FS--Diagnostic reagent for quantitative in vitro determination of total bilirubin in serum or plasma on Sysmex BX-Series.

Calcium P FS--Diagnostic reagent for quantitative in vitro determination of calcium in serum or plasma on Sysmex BX-Series.

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner