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PT. ALERE HEALTH

Authorized Representative in Indonesia

K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan
144 Products Represented
31 Manufacturers
Total Products
144
Manufacturers
31
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
2 products
1.4%
Kelas Resiko : B
72 products
50.0%
Kelas Resiko : C
51 products
35.4%
Kelas Resiko : D
19 products
13.2%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (144)
Complete portfolio registered with BPOM

Bioline™ HCV

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

DETERMINE HBsAg 2

Manufacturer:

ABBOTT DIAGNOSTICS MEDICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

BIOLINE Salmonella Typhi IgG/IgM Fast

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

AFINION™ Lipid Panel Control

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

DETERMINE™ HIV Early Detect

Manufacturer:

ABBOTT DIAGNOSTICS MEDICAL CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 31, 2025

BIOLINE™ Dengue NS1 Ag

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

BIOLINE™ Rotavirus

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

AFINION™ Lipid Panel

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

BIOLINE™ Dengue Duo

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2025

ALERE NT-proBNP for Alinity i Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

ALERE NT-proBNP for Alinity i Calibrators

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2025

BIOLINE™ Dengue IgG/IgM WB

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2025

BIOLINE™ Dengue IgG/IgM

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2025

PIMA ™ Bead Standard

Manufacturer:

ABBOTT RAPID DIAGNOSTIC JENA, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 2, 2025

ALERE NT-proBNP for ARCHITECT Calibrator Packs

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 31, 2024

AFINION™ ACR

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2024

ALERE NT-proBNP for ARCHITECT Reagent Packs

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2024

ALERE NT-proBNP for ARCHITECT Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

AFINION ™ ACR Control

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

ID NOW™ Influenza A & B2

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

COVID-19 Swab Transport Tube Accessory Pack

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2024

ID NOW ™ RSV

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

AFINION™ HbA1c

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

UroColor Control

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

ABON™ Urine Test Drug Screen Cassette (MDMA 500)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 30, 2024

ABON™ URINE TEST E-Z SPLIT KEY™ DRUG SCREEN CUP (COC300/THC50/AMP1000/MET1000/MOP300/BZO300/KET1000)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2024

ABON™ Urine Test Drug Screen Dip Card (AMP1000,MET1000,THC50,MOP300,BZO300)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 22, 2024

ABON™ URINE TEST DRUG SCREEN CASSETTE (MTD 300)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

ABON™ URINE TEST DRUG SCREEN CASSETTE (MET 1000)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2024

ABON™ Urine Test Drug Screen Cassette (AMP1000/THC50/MOP300)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 6, 2024

ABON™ Urine Test E-Z SPLIT KEY™ Drug Screen Cup (AMP 1000,THC 50,MDMA 500,MOP 300,BZO 300)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 6, 2024

ABON™ URINE TEST DRUG SCREEN CASSETTE (THC 50)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

ABON™ URINE TEST DRUG SCREEN CASSETTE (AMP 1000)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2024

ABON™ Urine Test Drug Screen Dip Card (COC300/AMP1000/MET1000/THC50/MOP300/BZO300)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

ABON™ Urine Test Drug Screen Cassette (MET1000/COC300/THC50/MOP300/BZO300/AMP1000)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

ABON ™ Urine Test E-Z SPLIT KEY™ Drug Screen Cup (COC300/AMP1000/MET1000/THC50/MOP300/BZO300)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

SD BIOLINE HCV

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 21, 2024

UroMeter 720 Urine Chemistry Analyzer

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2023

ID NOW ™ Instrument

Manufacturer:

ENERCON TECHNOLOGIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2023

SoToxa™ Oral Fluid Test Kit (OPI/COC/AMP/MAMP/THC/BZO)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

SoToxa™ Oral Fluid Test Kit (OPI/COC/AMP/MAMP/THC)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

CHOLESTECH LDX ™ Multianalyte Control

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

UroColor 11

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2023

EDTA Capillary Tubes

Manufacturer:

DRUMMOND SCIENTIFIC CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

ABON™ HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

CLEARVIEW ™ FOB One Step Fecal Occult Blood Test Device (Feces)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

ABON HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 31, 2023

CHOLESTECH LDX ™ TC

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

CHOLESTECH LDX TC/HDL/GLU

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

ABON HCV Hepatitis C Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 26, 2023

ABON HCV Hepatitis C Virus Rapid Test Device ( Serum/Plasma )

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 26, 2023

AFINION™ 2 and Accessories

Manufacturer:

SANMINA SCI

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

CHOLESTECH LDX Lipid Profile/GLU

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

SD BIOLINE FOB

Manufacturer:

STANDARD DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

CHOLESTECH LDX™ Lithium Heparin Capillary Tubes

Manufacturer:

DRUMMOND SCIENTIFIC CO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

CHOLESTECH LDX™ Capillary Plungers

Manufacturer:

DRUMMOND SCIENTIFIC CO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

Cholestech LDX™ Analyzer

Manufacturer:

HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

CHOLESTECH LDX ™ Calibration Verification

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

SoToxa™ Oral Fluid Mobile Test System

Manufacturer:

COGENT TECHNOLOGY LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 3, 2023

ABON Syphilis Ultra Rapid Test Device (Whole Blood/Serum/Plasma)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2023

ID NOW COVID-19 2.0

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2023

BIOLINE HIV/Syphilis Duo

Manufacturer:

ABBOTT DIAGNOSTICS KOREA, INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 19, 2023

ID NOW RSV Control Swab Kit

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

PANBIO COVID-19 Ag Rapid Test Device (Nasal)

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2023

PIMA CD4

Manufacturer:

ABBOTT RAPID DIAGNOSTIC JENA, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 30, 2023

ABON Multi Drug One Step Multi-Line Screen Test Panel (AMP/THC/MDMA/MOP/BZO) With Integrated E-Z Split Key Cup II ( Urine )

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

ABON™ MET One Step Methamphetamine Test Device (Urine)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ABON™ BZO One Step Benzodiazepines Test Device (Urine)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 10, 2023

BIOLINE HIV 1/2 3.0

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

ALERE NT-proBNP for Alinity Reagent Packs

Manufacturer:

AXIS-SHIELD DIAGNOSTICS, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 20, 2023

SD BIOLINE H. Pylori Ag

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

UroMeter 120 Urine Chemistry Analyzer and Accessories

Manufacturer:

STANDARD DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

ABBOTT Cholestech LDX Analyzer and Accessories

Manufacturer:

ALERE SAN DIEGO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

ID NOW™ Influenza A& B 2 Control Swab Kit

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

SD BIOLINE H. Pylori

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

PANBIO Dengue Early Rapid

Manufacturer:

STANDARD DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

PANBIO Dengue Duo Cassette

Manufacturer:

STANDARD DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

SD BIOLINE Malaria Ag P.f/P.v

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

ABON Multi-Drug One Step Multi-Line Screen Test Device (Urine) (AMP/THC/MOP)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

SD BIOLINE HIV/Syphilis Duo

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 6, 2022

ABON Multi-Drug One Step Screen Test Panel (Urine) (COC/AMP/MET/THC/MOP/BZO)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

ABON Multi-Drug One Step Multi-Line Screen Test Device (Urine) (MET/COC/THC/MOP/BZO/AMP)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

SureStep ™ Urine Test Drug Screen Cassette AB-PINACA (ABP)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

ABON Multi-Drug One Step Multi-Line Screen Test Panel with Integrated E-Z Split KeyTM Cup II (Urine) (COC, AMP, MET, THC, MOP, BZO)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

SureStep ™ Urine Test Drug Screen Dip Card (AMP1000/BZO300/CAR1000/COC300/MET500/MOP300/THC50)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

ABON Multi Drug One Step Multi-Line Screen Test Panel with Integrated E-Z Split Key Cup II (Urine) (COC/THC, AMP, MET, MOP, BZO, KET)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

ABON Multi-Drug One Step Screen Test Panel (Urine) (AMP / MET / THC / MOP / BZO)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2022

SD BIOLINE Malaria Ag P.f/Pan

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

ABON Multi-Drug One Step Screen Test Panel (Urine)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

ALERE Determine HIV-1/2

Manufacturer:

ALERE MEDICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 10, 2022

ALERE™ HIV Combo

Manufacturer:

ALERE MEDICAL CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 8, 2022

SD BIOLINE HAV IgG/IgM

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

SD BIOLINE HBsAg

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 7, 2022

SD UROCOLOR 10 Test Strips for Urinalysis (Blood/ Bilirubin/Urobilinogen/Ketone/Protein/Nitrite/Glucose/pH/Specific Gravity/Leukocytes)

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2022

SD Bioline Dengue NS1 Ag

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2022

SD BIOLINE Dengue IgG/IgM WB

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2022

SD BIOLINE Syphilis 3.0

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2022

SD Bioline Dengue Duo (Dengue NS1Ag+Ab Combo)

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2022

SD BIOLINE TB Ag MPT64 Rapid

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2022

SD BIOLINE Rotavirus

Manufacturer:

STANDARD DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

ID NOW ™ STREP A 2

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 24, 2022

BIOLINE Filariasis Test Strip

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

BIOLINE™ HBsAg

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 21, 2022

ABBOTT Cholestech LDX™ Lipid Profile

Manufacturer:

ALERE SAN DIEGO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

Abbott Cholestech LDX TC

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

ABBOTT Cholestech LDX TC/GLU

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2022

ABBOTT Cholestech LDX TC, HDL

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

ABBOTT Cholestech LDX TC/HDL/GLU

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2022

ABBOTT Cholestech LDX Lipid Profile/GLU

Manufacturer:

ALERE SAN DIEGO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2022

Bioline™ HBsAg WB

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 11, 2022

m-PIMA™ Analyser and Accessories

Manufacturer:

ABBOTT RAPID DIAGNOSTICS JENA GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

AFINION™ 2 and Accessories

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2022

PANBIO™ Covid-19 Ag Rapid Test Device Positive Control Kit

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

PANBIO Dengue Duo Cassette

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 4, 2022

PANBIO™ COVID-19 Ag Rapid Test Device

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

PANBIO Dengue Duo IgM Capture and IgG Capture ELISA

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2021

BIOLINE™ Strep A

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2021

BIOLINE™ Leptospira IgM

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2021

ID NOW™ Instrument

Manufacturer:

ENERCON TECHNOLOGIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 25, 2021

ID NOW™ COVID-19 Control Swab Kit

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

Panbio™ COVID-19 Ag Rapid Test Device (Nasal)

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2021

ID NOW™ COVID-19

Manufacturer:

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2021

BIOLINE™ HBsAg

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 16, 2021

BIOLINE™ H.pylori. Ag

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2021

ABBOTT UroColor 10

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2021

BIOLINE ™ Malaria Ag P.f / Pan

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2021

Bioline™ H.pylori

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2021

BIOLINE™ HAV IgG / IgM

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2021

Bioline™ Influenza Antigen

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

Bioline ™ Malaria Ag P.f / P.v

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

DETERMINE™ Syphilis TP

Manufacturer:

ABBOTT DIAGNOSTICS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 22, 2021

Bioline™ TB Ag MPT64

Manufacturer:

ABBOTT DIAGNOSTICS KOREA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2021

ABBOTT Capillary Tube

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

NycoCard ™ Reader II and Accessories

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2020

Afinion™ HbA1c Control

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2020

AFINION™ CRP

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2020

NYCOCARD™ CRP

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2020

AFINION™ CRP Control

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2020

NYCOCARD ™ HbA1c Control

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2020

ABON™ Multi-Drug One Step Screen Test Panel (Urine) (COC/AMP/MET/THC/MOP/K2/BZO)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2020

NYCOCARD ™ HbA1c

Manufacturer:

ABBOTT DIAGNOSTICS TECHNOLOGIES AS.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2020

ABON BZO One Step Benzodiazepines Test Strip (Urine)

Manufacturer:

ABON BIOPHARM (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2020

SD BIOLINE HIV 1/2 3.0

Manufacturer:

STANDARD DIAGNOSTICS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 20, 2019

SD BIOLINE HBsAg WB

Manufacturer:

STANDARD DIAGNOSTICS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 21, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025