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PT. RAFA TOPAZ MAIN

Authorized Representative in Indonesia

Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur
127 Products Represented
29 Manufacturers
Total Products
127
Manufacturers
29
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
15 products
11.8%
Kelas Resiko : B
63 products
49.6%
Kelas Resiko : C
47 products
37.0%
Kelas Resiko : D
2 products
1.6%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (127)
Complete portfolio registered with BPOM

LABSTRIP U11 Plus Urinalysis

Manufacturer:

77 ELECTRONICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

LABSTRIPS U11 Plus GL Urine Test Strip

Manufacturer:

77 ELECTRONICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

LabUReader Plus 2 semi-automated urine analyzer

Manufacturer:

77 ELECTRONICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

LABUMAT 2 Automated Urine Chemistry Analyzer

Manufacturer:

77 ELECTRONICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2025

DocUReader 2 Pro Urine Analyzer and Accessories

Manufacturer:

77 ELECTRONICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2025

URISED 3 Automated Urine Sediment Analyzer

Manufacturer:

77 ELECTRONICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2025

URISED Mini Urine Sediment Analyzer and Accessories

Manufacturer:

77 ELECTRONICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2025

LORNE RPR Carbon Kit

Manufacturer:

LORNE LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

LORNE Anti-B Monoclonal Blood Grouping Reagent

Manufacturer:

LORNE LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

LORNE ASO Latex Kit

Manufacturer:

LORNE LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2024

LORNE Anti-A Monoclonal Blood Grouping Reagents

Manufacturer:

LORNE LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2024

LORNE Anti-D Duoclone Monoclonal

Manufacturer:

LORNE LABORATORIES LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2024

LORNE TPHA Microtitre Plate Kit

Manufacturer:

LORNE LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2024

ACRO Multi-Drug 7 Drugs Rapid Test 1-Step Cup (Urine) (MOP300/MET1000/COC300/BZO300/AMP1000/THC50/CAR2000)

Manufacturer:

ACRO BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

ACRO Multi-Drug 7 Drugs Rapid Test 1-Step Cup (Urine) (MDMA500/MET500/COC150/BZO200/AMP500/THC25/CAR2000)

Manufacturer:

ACRO BIOTECH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

ACRO Multi-Drug 10 Drugs Rapid Test 1-Step Cup (Urine) (OPI300/MDMA500/COC150/PCP25/MTD200/BZO200/AMP500/MET500/CAR2000/THC25)

Manufacturer:

ACRO BIOTECH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

ACRO HBsAb Rapid Test Dipstick (Whole blood/Whole Blood/Serum/Plasma)

Manufacturer:

ACRO BIOTECH INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2024

ACRO Multi-Drug 7 Drugs Rapid Test 1-Step Cup (Urine) (MDMA500/MET1000/COC300/BZO300/AMP1000/THC50/CAR2000)

Manufacturer:

ACRO BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 3, 2024

PRORAD Atlas Ultraportable X-Ray

Manufacturer:

PROGNOSYS MEDICAL SYSTEM PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2024

ACRO Multi-Drug 10 Drugs Rapid Test Cup (Oral Fluid) (OPI40/MET50/COC20/AMP50/PCP10/BZO50/ MTD30/MDMA50/CAR300/THC12)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 28, 2024

ACRO HbA1c Rapid Test Cassette (Whole Blood)

Manufacturer:

ACRO BIOTECH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

ACRO Multi-Drug 10 Drugs Rapid Test 2-Step Cup (Urine) (MOP300/MDMA500/COC300/THC50/AMP1000/MET1000 /MTD300/BAR300/BZO300/BUP10)

Manufacturer:

ACRO BIOTECH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2024

PETUNIA MCX 50 (LED) and Accessories

Manufacturer:

MICROS PRODUKTIONS- & HANDELSGMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 27, 2023

RAZOR Manual Rotary Microtome and Accessories

Manufacturer:

MICROS PRODUKTIONS- & HANDELSGMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2023

MICROS Daffodil MCX100 and Accesories

Manufacturer:

MICROS PRODUKTIONS- & HANDELSGMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2023

INStest ™ Influenza A/B and Respiratory Syncytial Virus RT-qPCR Kit

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

ACRO Multi-Drug 10 Drugs Rapid Test 1 Step Cup (Urine) (OPI2000/MDMA500/COC300/PCP25/MTD300/ BZO300/AMP1000/MET1000/CAR2000/THC50)

Manufacturer:

ACRO BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

MAMMOSCAN Full Field Digital Mammography System

Manufacturer:

LINEV ADANI

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 15, 2023

OZCAN ATAON Oxygen Concentrator For Medical Pipelines

Manufacturer:

ÖZCAN KARDEŞLER TIP CIHAZLAR SANAYI VE TICARET LTD. STI.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2023

miniiSED ESR Analyzer

Manufacturer:

ALCOR SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2023

ACRO Malaria P.f./P.v. Rapid Test Cassette (Whole Blood)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2023

ELITE InGenius

Manufacturer:

ELITECHGROUP S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2023

ALIFAX HB&L Uroquattro and Accessories

Manufacturer:

ALIFAX SRL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2023

ALIFAX ALFRED 60/AST and Accessories

Manufacturer:

ALIFAX SRL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2023

MYR Semi Automated Rotary Microtome

Manufacturer:

MEDICAL SPECIALTIES MYR, SL.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 29, 2022

ACRO Adenovirus Rapid Test Cassette (Swab)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 10, 2022

BEIJING SUCCEDER SF-8100 Fully Automated Coagulation Analyzer and Accessories

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

SUCCEEDER SF-400 Semi Automated Coagulation Analyzer and Accessories

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2022

ECHOSON PINIT Bladder Scanner

Manufacturer:

ECHO-SON S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

ACRO SMA Rapid Test Cassette (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2022

ACRO MDMA500 Rapid Test Dipstick ( Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

ACRO iGFB-1 Rapid Test Cassette ( Vaginal Discharge )

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

ACRO BAR300 Rapid Test Dipstick (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

ACRO AMP Rapid Test Cassette (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2022

ACRO BZO Rapid Test Dipstick (urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

ACRO MCAT Rapid Test Dipsticks (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

ACRO AMP 1000 Rapid Test Dipstick ( Urine )

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

ACRO MCAT Rapid Test Cassette (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

ACRO BAR300 Rapid Test Cassette (Urine)

Manufacturer:

HANGZHOU ALLTEST BIOTECH CO. MLTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 3, 2022

ACRO Multi-Drug 3 Drugs Rapid Test Panel (Urine) (AMP/MET/THC)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2022

ACRO Multi-Drug 9 Drugs Rapid Test Panel Urine (MOP/MDMA/COC/BZO/AMP/MET/K2/THC/PCP)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2022

ACRO Multi-Drug 3 Drugs Rapid Test Cassette (Urine) (AMP1000+MET1000+THC50)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2022

ACRO Multi-Drug 6 Drugs Rapid Test Panel (Urine) (MOP/COC/AMP/MET/BZO/THC)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2022

ACRO Multi-Drug 8 Drugs Rapid Test 1-Step Cup (Urine) (MOP/MDMA/COC/THC/AMP/MET/MTD/BUP)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2022

ACRO COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

ACRO 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

ACRO Multi-Drug 8 Drugs Rapid Test Panel Urine (MOP/MDMA/COC/BZO/AMP/MET/K2/THC)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2022

ACRO Multi-Drug 7 Drugs Rapid Test Panel (Urine) (MOP/MDMA/COC/AMP/MET/K2/THC)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2022

ACRO Multi-Drug 5 Drugs Rapid Test Panel (Urine) (AMP/MOP/THC/MET/BZO)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2022

ACRO Multi-Drug 16 Drugs Rapid Test Panel (AMP/BZO/COC/MDMA/MET/MOP/OPI/THC/K2/ABP/CAT/MCAT/KET/MTD/UR-144/MDPV)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2022

ACRO Influenza A+B Rapid Test Dipstick (Swab/Nasal Aspirate)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

ACRO MET Rapid Test Dipstick (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2022

ACRO MET Rapid Test Cassette ( Urine )

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

ACRO Leptospira IgG/IgM Rapid Test Cassette ( WB/Serum/Plasma )

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

ACRO H. pylori Antibody Rapid Test Cassette (Whole Blood /Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

ACRO Multi-Drug 8 Drugs Rapid Test 2 Step Cup (Urine) (AMP1000/COC300)+(MET1000/MOP300)+THC50+PCP25+BAR200+BZO300

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 25, 2022

ACRO Salmonella Typhi Antigen Rapid Test Cassette (feces)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

ACRO Influenza A+B Rapid Test Cassette (Swab/Nasal Aspirate)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

ACRO Synthetic Marijuana (K2) Rapid Test Dipstick ( Urine )

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

ACRO Multi-Drug 3 Drugs Rapid Test Panel (Urine) (AMP/MOP/THC)

Manufacturer:

HANGZHOU ALTEST BIOTECH, CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 25, 2022

ACRO MOP300 Rapid Test Dipstick ( Urine )

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2022

ACRO Malaria P.f./Pan Rapid Test Cassette (Whole Blood)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2022

ACRO Strep B Rapid Test Cassette (Swab)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2022

ACRO Tetanus Rapid Test Cassette (Whole Boold/Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

ACRO H. Pylori Antigen Rapid Test Cassette (Feces)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2022

ACRO RSV Rapid Test Cassette (Nasopharyngeal swab/Nasal Aspirate)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2022

ACRO Breath Alcohol Test (0.08 Percent BAC)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2022

ACRO Strep A Rapid Test Cassette

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2022

ACRO 6-MAM Rapid Test Cassette (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

ACRO Adenovirus Rapid Test Cassette (Feces)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2022

ACRO Legionella pneumophila Rapid Test Cassette (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2022

ACRO Typhoid Rapid Test Cassette (Whole Blood /Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

ACRO Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2022

ACRO 6-MAM10 Rapid Test Dipstick ( Urine )

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ACRO Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2022

ACRO Malaria P.f. Rapid Test Cassette (Whole Blood)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ACRO Rapid Test Urinalysis Reagent Strips

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

ACRO Filariasis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 16, 2022

ACRO Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

ACRO Gonorrhea Rapid Test Cassette (Swab)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

ACRO Chagas Rapid Test Cassette (Whole Blood/Serum/Plasma))

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 12, 2022

ACRO Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma))

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ACRO HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2022

ACRO Mycoplasma Pneumoniae Antigen Rapid Test Cassette (Throat Swab)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2022

ACRO Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 5, 2022

SUCCEEDER Activated Partial Thromboplastin Time Kit (APTT Liquid)

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2022

ACRO Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2022

SUCCEEDER Activated Partial Thromboplastin Time Kit (APTT Powder)

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2022

SUCCEEDER Coagulation Control II Powder

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 1, 2022

SUCCEEDER Prothrombin Time Kit (PT) Powder

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2022

SUCCEEDER D-Dimer Control I Powder

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

SUCCEEDER Thrombin Time Kit (TT) Powder

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

SUCCEEDER D-Dimer Kit Liquid

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2022

SUCCEEDER Thrombin Time Kit (TT) Liquid

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2022

SUCCEEDER Fibrinogen Degradation Product Kit (FDP)

Manufacturer:

BEIJING SUCCEEDER TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 20, 2022

SKYLA ™ Hi CRP Reagent Kit

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2022

ACRO HBcAb Rapid Test Cassette (Serum/ Plasma)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 27, 2022

ACRO THC Rapid Test Cassette (Urine)

Manufacturer:

ACRO BIOTECH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

NORMA-iDil3

Manufacturer:

NORMA DIAGNOSTIKA GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2022

NORMA-iLyse3

Manufacturer:

NORMA DIAGNOSTIKA GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2022

NORMA-iSol3

Manufacturer:

NORMA DIAGNOSTIKA GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2022

NORMA-iClean5

Manufacturer:

NORMA INSTRUMENT ZRT.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 26, 2022

NORMA-iDil5

Manufacturer:

NORMA INSTRUMENT ZRT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2022

NORMA-iLyse5

Manufacturer:

NORMA INSTRUMENT ZRT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2022

NORMACONT5+ Kit K1

Manufacturer:

NORMA INSTRUMENTS ZRT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2022

NORMA Icon 3 Hematology Analyzer and Accessories

Manufacturer:

NORMA DIAGNOSTIKA GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2022

NORMA Icon 5 Hematology Analyzer and Accessories

Manufacturer:

NORMA INSTRUMENTS ZRT.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2022

SKYLA™ HB1 Lipid Panel

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 24, 2021

SKYLA Hi Analzyer and Accessories

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

LIFOTRONIC Real-Time Quantitative Thermal Cycler

Manufacturer:

SUZHOU MOLLARAY CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2021

Vision Hema 8Pro

Manufacturer:

WEST MEDICA PRODUKTIONS UND HANDELS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 21, 2021

LAVENDER MCX100 LCD Microscope and Accessories

Manufacturer:

MICROS PRODUKTIONS- & HANDELSGMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 5, 2020

LDN Dopamine ELISA Fast Track

Manufacturer:

LABOR DIAGNOSTIKA NORD GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

Serotonin ELISA Fast Track

Manufacturer:

LABOR DIAGNOSTIKA NORD GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

LDN Noradrenaline ELISA Fast Track

Manufacturer:

LABOR DIAGNOSTIKA NORD GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

AUTOBIO Sample Pretreatment Reagent

Manufacturer:

AUTOBIO LABTEC INSTRUMENTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2019

AUTOBIO Automated Mass Spectrometry Microbial Identification System and Accessories

Manufacturer:

AUTOBIO LABTEC INSTRUMENTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2019

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

Last updated: December 2025