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Manufacturer profile

FUJIREBIO DIAGNOSTICS, INC.

IndonesiaUnited States20 products registered
VerifiedKemenkes (Ministry of Health) · official registry
20
Total Products
20
Product Names
1
Product Classes
2
Risk Classes
Regulatory footprint
Search FUJIREBIO DIAGNOSTICS, INC. across other regulatory registries
Risk classification breakdown
Distribution of products across risk classes
Kelas Resiko : B420.0% of total
Kelas Resiko : C1680.0% of total
Product class portfolio
Products organized by product class
Kelas : 2
ARCHITECT BNP Controls, ALINITY i BNP Controls, ALINITY i CA 19-9XR Reagent Kit, ALINITY i CA 19-9XR Calibrators, ARCHITECT CA 19-9 XR Controls ... and 15 more products in this class
20 Products
Recent registrations (20 most recent)
Most recently registered products with Ministry of Health
ARCHITECT BNP Controls
Oct 2, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i BNP Controls
Oct 1, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CA 19-9XR Reagent Kit
Oct 1, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CA 19-9XR Calibrators
Oct 1, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 19-9 XR Controls
Sep 24, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CA 125 II Reagent Kit
Aug 4, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HE4 Reagent Kit
Aug 4, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HE4 Controls
Aug 4, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CA 125 II Calibrators
Aug 4, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CA 15-3 Calibrators
Mar 5, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 15-3 Controls
Mar 5, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 15-3 Reagent Kit
Mar 5, 2024
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Sirolimus Calibrators
Oct 30, 2023
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Sirolimus Whole Blood Precipitation Reagent
Oct 27, 2023
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Cyclosporine Whole Blood Precipitation Reagent Kit
Oct 26, 2023
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Sirolimus Whole Blood Precipitation Reagent
Oct 26, 2023
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Sirolimus Reagent Kit
Oct 25, 2023
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Methotrexate Reagent Kit
Jul 4, 2023
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Thyroglobulin Calibrators
Jun 21, 2023
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY and CYFRA 21-1 Calibrators
Nov 28, 2022
Class
Kelas : 2
Risk Class
Kelas Resiko : C
About this profile

FUJIREBIO DIAGNOSTICS, INC. from United States is a medical device manufacturer with 20 registered products in the Indonesia Ministry of Health database through Pure Global AI's free platform. The company produces 20 unique product types across 1 product class.

This page provides comprehensive manufacturer intelligence including complete product portfolio, risk class distribution, and product class analysis. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify manufacturers, analyze portfolios, and discover partnership opportunities efficiently.