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  • PENGUMUMAN SENARAI KIT UJIAN UNTUK PENGESAN INFLUENZA A DAN INFLUENZA B YANG BERDAFTAR DENGAN PIHAK BERKUASA PERANTI PERUBATAN (MDA)

PENGUMUMAN SENARAI KIT UJIAN UNTUK PENGESAN INFLUENZA A DAN INFLUENZA B YANG BERDAFTAR DENGAN PIHAK BERKUASA PERANTI PERUBATAN (MDA)

MDA ingin memaklumkan bahawa terdapat 33 kit ujian untuk digunakan bagi pengesanan Influenza A dan Influenza B yang telah berdaftar dengan MDA

Adalah dimaklumkan juga bahawa penggunaan kit ujian untuk pengesanan Influenza A dan Influenza B hanya boleh diguna pakai untuk kegunaan PROFESIONAL SAHAJA. Ianya TIDAK BOLEH SESEKALI DIGUNAKAN SEBAGAI KIT UJIAN KENDIRI.

Senarai dibawah menunjukkan kit ujian Influenza A dan Influenza B yang berdaftar dengan MDA untuk rujukan umum.

Rujukan mengenai kit ujian influenza A dan inluenza B yang berdaftar juga boleh diperolehi melalui link berikut.

https://mdar.mda.gov.my/frontend/web/index.php?r=carian

 

PERANTI PERUBATAN UNTUK INLUENZA A AND INFLUENZA B YANG BERDAFTAR

a) RT PCR

 

NO.

COMPANY NAME

NAME OF DEVICE

BRAND

REGISTRATION NO

TYPE OF ASSAY

IDENTIFIER

ISSUED DATE

VALID UNTIL

1

AXISBIO DIAGNOSTICS SDN BHD

SOLANA INFLUENZA A+B ASSAY

QUIDEL

IVDC78671339618

RT-PCR

M5176

M5172

12-10-2018 

11-10-2023

2

MEDICAL INNOVATION VENTURES SDN BHD

GENOAMP REAL-TIME RT-PCR INFLUENZA

GENOAMP

IVDC55030360618

RT-PCR

GRA2012

14-12-2018

13-12-2023

3

ROCHE DIAGNOSTICS (M) SDN. BHD.

COBAS® INFLUENZA A/B & RSV

COBAS

IVDC8665519-29702

RT-PCR

08160104190

07402686190

04-06-2019

03-06-2024

4

INTERSCIENCE SDN BHD

VIASURE RESPIRATORY VIRUS-INFLUENZA A & B REAL TIME PCR DETECTION KIT

CERTEST

IVDC8404719-37487

RT-PCR

VS­-YIA106L

VS-YIA106H

VS-YIA112L

VS-YIA112H

VS-YIA113L

VS-YIA113H

VS-YIB106L

VS-YIB106H

VS-YIB112L

VS-YIB112H

09-12-2019

08-12-2024

5

ROCHE DIAGNOSTICS (M) SDN. BHD.

COBAS® INFLUENZA A/B

ROCHE

IVDC8132919-29705

RT- PCR

        07341890190

07402660190

04-06-2019

03-06-2024

6

ADT BIOTECH SDN BHD

INFLUENZA SCREEN & TYPE RT-PCR KIT 4.0

REALSTAR

IVDC10340720-38830

RT-PCR

164013

14-01-2020

13-01-2025

7

INTERSCIENCE SDN BHD

VIASURE FLU A, FLU B & RSV REAL TIME PCR DETECTION KIT

VIASURE

IVDC6173320-42707

RT- PCR

VS-ABR106L

VS-ABR106H

VS-ABR112L

VS-ABR112H

VS-ABR113L

VS-ABR113H

13-04-2020

12-04-2025

8

BMS DIAGNOSTICS (M) SDN BHD

ARIES® FLU A/B & RSV ASSAY

ARIES

IVDC97248376719

RT- PCR

50-10020

CN-0335-01

21-12-2018

20-12-2023

 

b) RTK ANTIGEN

 

No.

COMPANY NAME

NAME OF DEVICE

BRAND

REGISTRATION NO

TYPE OF ASSAY

IDENTIFIER

ISSUED DATE

VALD UNTIL

I

BIOMERIEUX MALAYSIA SDN BHD

BIONEXIA INFLUENZA A+B

BIONEXIA

IVDC96763115718

RTK ANTIGEN

410918

11-01-2018

10-01-2023

2

GLOBAL SCIENCE SDN BHD

CERTEST INFLUENZA A+B+RSV+ADENO RESP.

CERTEST

IVDC11852301818

RTK ANTIGEN

ZV862001P

26-09-2018

25-09-2023

3

ALL EIGHTS (M) SDN BHD

INFLUENZA A&B-N

ESPLINE

IVDC9478090017

RTK ANTIGEN

231425

15-12-2017

14-12-2022

4

GLOBAL SCIENCE SDN BHD

GENEDIA® INFLUENZA A/B AG II TEST KIT

GENEDIA®

IVDC99013329018

RTK ANTIGEN

151G

29-10-2018

28-10-2023

5

AXISBIO DIAGNOSTICS SDN BHD

QUICKVUE INFLUENZA A+B

QUICKVUE

IVDC54312138118

RTK ANTIGEN

0486501 0484201

0484301

1164601

1033500

1013002

0468703

1129600

20183

06-02-2018

05-02-2023

6

AMD SOLUTIONS SDN BHD.

RAPID INFLUENZA A+B ANTIGEN TEST CARD

BOSON BIOTECH

IVDB17342395319

RTK ANTIGEN

1N18C5

21-02-2019

20-02-2024

7

SETIA SCIENTIFIC SOLUTION

INFLUENZA A & B RAPID TEST

BIOCREDIT

IVDC83123399419

RTK ANTIGEN

G10RHA20

G10RHS25

26-04-2019

25-04-2024

8

SETIA SCIENTIFIC SOLUTION

INFLUENZA A+B RAPID TEST

JUSCHEK

IVDC17278404419

RTK Antigen

IIN-502

12-06-2019

11-06-2024

9

VQM MARKETING SDN. BHD.

INFLUENZA A+B RAPID TEST CASSETTE

ALLTEST

IVDC55409391919

RTK Antigen

IIN-502

08-03-2019

07-03-2024

10

SETIA SCIENTIFIC SOLUTION

ADENOVIRUS/ RSV /INFLUENZA A+B COMBO RAPID TEST

JUSCHEK

IVDC10793320-42415

RTK Antigen

IARI-AR535

22-04-2020

21-04-2025

11

VQM MARKETING SDN. BHD.

RSV/Influenza A+B Combo Rapid Test Cassette

ALLTEST

IVDC6315620-42452

RTK Antigen

IRIC-525

13-04-2020

12-04-2025

12

MERLIN MEDIC SDN BHD

ASAN EASY TEST® INFLUENZA A/B (D)

ASAN

IVDC7582720-42405

RTK Antigen

AM2851-K

13-04-2020

12-04-2025

13

MERLIN MEDIC SDN BHD

ONSITE™ INFLUENZA A/B AG / RSV AG / ADENOVIRUS AG RAPID TEST

ONSITE™

IVDC2926620-42377

RTK Antigen

R0187C

R0189C

R0186C

21-04-2020

20-04-2025

14

MERLIN MEDIC SDN BHD

MERLIN INFLUENZA A/B AG / RSV AG / ADENOVIRUS AG COMBO RAPID TEST

MERLIN INFLUENZA A/B AG / RSV

AG / ADENOVIRU S AG COMBO RAPID TEST

IVDC7291920-43603

RTK Antigen

MM18C

MM19C

MM20C

29-05-2020

28-05-2025

15

MERLIN MEDIC SDN BHD

ASAN EASY TEST® INFLUENZA A/B(F)

ASAN

IVDC4742420-43076

RTK Antigen

AM2851-K

EASY CHECK F-100

15-05-2020

14-05-2025

16

ABBOTT DIAGNOSTICS HEALTH SDN BHD

CLEARVIEW EXACT INFLUENZA A & B

CLEARVIEW

IVDC89477332018

RTK Antigen

IIN-501

15-11-2018

14-11-2023

17

ABBOTT DIAGNOSTICS HEALTH SDN BHD

SD BIOLINE INFLUENZA AG IVD

SD BIOLINE

IVDC85900371019

RTK-Antigen

19FK12

19FK13

31-12-2018

30-12-2023

18

NEOSCIENCE SDN BHD

STANDARD™ Q INFLUENZA A/B TEST

STANDARD™ Q INFLUENZA A/B TEST

IVDC10518519-29400

RTK-Antigen

QINF01G

QINF01G -1

QINF01G -2

QINF01G -3

QINF01G -4

QINF01G -5

QINF01G -6

C-INF01G

28-05-2019

27-05-2024

19

NEOSCIENCE SDN BHD

STANDARD™ F INFLUENZA A/B FIA

STANDARD™ F INFLUENZA A/B FIA

IVDC99466349418

RTK-Antigen

FINF01G-1

FINF01G

FINF01G-2

FINF01G-3

FINF01G-4

FINF01G-5

FINF01G-6

06-12-2018

05-12-2023

20

EXZA MEDICAL SDN BHD

ONE STEP INFLUENZA A&B TEST WONDFO

WONDFO

IVDC7405222-88805

RTK-Antigen

W71-C

24-03-2022

23-03-2027

21

ABBOTT DIAGNOSTICS HEALTH SDN BHD

BIOLINE™ INFLUENZA AG A/B/A(H1N1)

BIOLINE™

IVDC28690356118

         RTK- Antigen

19FK32

18-12-2018

17-12-2023

22

MEDICAL INNOVATION VENTURES SDN BHD

PRODETECT FLU A & B RAPID TEST

PRODETECT

IVDC23999349118

         RTK-Antigen

PR-FLU

05-12-2018

04-12-2023

23

GLOBAL SCIENCE SDN BHD

FLU A+B ANTIGEN RAPID TEST DEVICE (COLLOIDAL GOLD)

KAIBILI

IVDC76636341518

         RTK-Antigen

C0201010A

13-11-2018

12-11-2023

 

c) ANTIGEN ASSAY DAN POCT MOLECULAR

 

No.

COMPANY NAME

NAME OF DEVICE

BRAND

REGISTRATION NO

TYPE OF ASSAY

IDENTIFIER

ISSUED DATE

VALID UNTIL

1

AXISBIO DIAGNOSTICS SDN BHD

SOFIA INFLUENZA A+B

QUIDEL

IVDC64539138018

ANTIGEN ASSAY

20254

1169100

1170700

1204701

1033500

1184003

1216202

1168500

1200100

07-02-2018

06-02-2023

2

ABBOTT DIAGNOSTICS HEALTH SDN BHD

ID NOW INFLUENZA A & B 2

ID NOW

IVDC54867304918

POCT-Molecular      (Isothermal)

427-000

NAT-000 / NAT-000S

425-080

428-000

08-10-2018

07-10-2023

 

Data dikemaskini pada 2 Ogos 2022

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 11 August 2022.
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