N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET(N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET) - India CDSCO Medical Device Registration

N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET(N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000005_f2f1d7c15a36a64169dcef856e14cabf_9fc90b698a0cc986d1c6e00423112634. This device is marketed under the brand name Lp-PLA2 Reagent. The license holder is M/s. Agappe Diagnostics Ltd., and it is classified as Device Class Class B. The approving authority is Kerala.

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CDSCO Registered

Class Class B

N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET(N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET)

UID: MFG/IVD/2020/000005_f2f1d7c15a36a64169dcef856e14cabf_9fc90b698a0cc986d1c6e00423112634

Brand Name

Lp-PLA2 Reagent

License Holder

M/s. Agappe Diagnostics Ltd.

Device Class

Class B

Approving Authority

Kerala

Product Information

Diagnostic Medical Device intended for the preparation of calibration curve for N- Acetyl-β-D-Glucosaminidase (Lp-PLA2 Reagent) estimation

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Alpha-2-macroglobulin - i3

Brand: Lp-PLA2 Reagent

M/s. Agappe Diagnostics Ltd.

N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET(N- ACETYL-β-D-GLUCOSAMINIDASE CALIBRATOR SET) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Alpha-2-macroglobulin - i3

25- Hydroxy Vitamin D Control

Haptoglobin (Haptoglobin )

CERULOPLASMIN KIT (CERULOPLASMIN KIT )

IMMUNOGLOBULIN G KIT (IMMUNOGLOBULIN G KIT )

UREA-B KIT

COUNT L3 Reagent (COUNT L3 Reagent )

LDL-CHOLESTEROL CALIBRATOR SERUM

QUALICHECK PATH (QUALICHECK PATH )

RETINOL BINDING PROTEIN REAGENT KIT(RETINOL BINDING PROTEIN REAGENT KIT)

BASE WASHING SOLUTION (WASHING SOLUTION)(BASE WASHING SOLUTION (WASHING SOLUTION))

Alpha-2-macroglobulin - i3

25- Hydroxy Vitamin D Control

Haptoglobin (Haptoglobin )

CERULOPLASMIN KIT (CERULOPLASMIN KIT )

IMMUNOGLOBULIN G KIT (IMMUNOGLOBULIN G KIT )

UREA-B KIT

COUNT L3 Reagent (COUNT L3 Reagent )

LDL-CHOLESTEROL CALIBRATOR SERUM

QUALICHECK PATH (QUALICHECK PATH )