Saturday, December 4, 2021

Senarai Kit Ujian Kendiri COVID-19 Yang Diluluskan Oleh MDA Setakat 15 November 2021

Kementerian Kesihatan Malaysia (KKM) telah memperluas penjualan kit ujian kendiri COVID-19 dengan kerjasama Kementerian Perdagangan Dalam Negeri dan Hal Ehwal Pengguna (KPDNHEP) bagi meletakkan syarat-syarat supaya dapat memperoleh Kelulusan Bersyarat dari Medical Device Authority (MDA) untuk penjualan kit ujian kendiri COVID-19.

Berikut adalah senarai kit ujian COVID-19 yang diluluskan oleh KKM setakat ini:

  1. Salixium-COVID-19 Rapid Antigen Rapid Test (Saliva/Nasal Swab Samples)
  2. Gmate COVID-19 Ag Saliva for Home Use
  3. BERIGHT-COVID-19 Antigen Rapid Test Devide (Oral Fluid)
  4. JusChek COVID-19 Antigen Rapid Test (Oral Fluid)
  5. ALLTest COVID-19 Antigen Rapid Trst (Oral Fluid)
  6. Longsee 2019-nCOV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatographu) Home based Use
  7. Sichuan Xincheng SARS-CoV-2 Antigen Assay
  8. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-testing)
  9. STANDARD Q COVID-19 Ag Saliva Home Test
  10. ProDetect COVID-19 Antigen Rapid Self-Test (Saliva)
  11. NEWGRNE Bioengineering COVID-19 Antigen Detection Kit
  12. Lituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit
  13. GRUENBANKA SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)
  14. Humasis COVID-19 Ag Home Test (Self Test)
  15. LYHET Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
  16. ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid)
  17. Beright SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-Testing
  18. Roche SARS-CoV-2 Antigen Self-Test Nasal
  19. ARISTA COVID-19 Antigen Rapid Test
  20. Whistling Test 2019-nCoV Saliva Ag Easy Test
  21. Newgene Bioengineering COVID-19 Antigen Detection Kit (For Home Self Use)
  22. TIB SARS CoV-2-Antigen Rapid Test Kit Saliva
  23. V-check 2019-nCoV Ag Saliva Rapid Test Covid
  24. StrongStep SARS-CoV Antigen Rapid Test (Self-Test)
  25. Merlin SARS-CoV-2 Antigen Rapid Test Cassette (Saliva)
  26. Merlin SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab)
  27. LEPU SARS-CoV Antigen Rapid Test
  28. STANDARD Q COVID-19 Ag Home Test
  29. SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home Use Self Test Kit
  30. WONDFO 2019-nCoV Antigen Test (Lateral Flow Method) Self Test Saliva
  31. Lituo COVID-19 Antigen Detection Kit (Colloidal Gold)
  32. Tigsun COVID-19 Saliva Antigen Rapid Test
  33. NEWGENE COVID-19 Antigen Detection Kit
  34. Ninonasal Self Test
  35. Sars-CoV-2 Antigen Rapid Test Cassette (Merlin)
  36. Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold)
  37. Altest SARS-CoV-2 Antigen Rapid Test (Nasal swab) for Self-Testing
  38. Zosbio 2019-nCoV Ag Rapid Test (Immunochromatography)
  39. Sejoy SARS-CoV-2 Antigen Rapid Test Cassette
  40. Wondfo 2019 nCoV Antigen Test (Lateral Flow Method)
  41. TestNGo COVID-19 Rapid Antigen Saliva Test SARS-CoV-2 Antigen Test Kit (Self-Test)
  42. CAMTESCH COVID-9 Antigen Rapid Self-Test Kit
  43. Ecotest COVID-19 Antigen Nasal Test Kit
  44. Hopegene COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
  45. Empro Biomed COVID-19 Ag Nasal Self-Test
  46. Wiz Biotech SARS-CoV-2 Antigen Rapid Test
  47. Ecotest Covid019 Antigen Rapid Test Devide (Saliva)
  48. Labnovation SARS-CoV-2 Antigen Saliva Rapid Test Kit
  49. OnSite COVID-19 Ag Self-Test
  50. NEWGENE COVID-19 Antigen Detection Kit
  51. BERIGHT SARS-CoV-2 (covid-19) Antigen Rapid Test Oral Fluid (Saliva)
  52. ARISTA COVID-19 Antigen Rapid Test
  53. Wikang SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home use
  54. VivaDiag SARS-CoV-2 Ag Rapid Test
  55. SGTI-flex COVID-19 Antigen
  56. NEWGENE COVID-19 Antigen Detection Kit
  57. ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) For Self Testing
  58. RapidFor SARS-CoV-2 Saliva Antigen Test Kit (Self Testing)
  59. Singclean COVID-19 Antigen Test Kit (Colloidal Gold)
  60. Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
  61. Axial Health COVID-19 Saliva Antigen Rapid Test (Colloid Gold Immunochromatography)
  62. Axial Health COVID-19 Salivary Antigen Rapid Test (Colloid Gold Immunochromatography)
  63. CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self-Test)
  64. One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)
  65. Ecotest COVID-19 Antigen Rapid Test Device (Nasal Swab)
  66. Szybio COVID-19 Antigen Rapid Test Kit (Saliva)
  67. ProDetect™ COVID-19 Antigen Rapid Self-Test
  68. Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
  69. Clungene® COVID-19 Antigen Rapid Test
  70. VivaDiagTM SARS-CoV-2 Ag Saliva Rapid Test

Semua kit ujian COVID-19 boleh dilakukan dengan sendiri di mana-mana sahaja melalui ujian air liur atau rongga hidung. Harga jualan kit ujian COVID-19 telah diselaraskan oleh kerajaan dengan harga borong sebanyak RM16 dan RM19.90 untuk harga runcit.

Jika menggunakan kit ujian COVID-19 dan keputusannya adalah positif COVID-19, pesakit tetap perlu menjalani ujian RT-PCR untuk mengesahkannya.

Berikut merupakan panduan untuk menggunakan kit ujian COVID-19 bagi ujian air liur dan rongga hidung:

Kit Ujian COVID-19 Air Liur 

Kit Ujian COVID-19 Rongga Hidung

Baca Sekarang : Ini Kenyataan Rasmi KKM Berkenaan Produk Konfeksi Termasuk Biskut Popular Lain Di Malaysia

Sumber : Medical Device Authority

Anis Maisarah
Nissy | 23 Tahun | Minat Thriller & Horror Movie | Eat Well, Live Well
ARTIKEL BERKAITAN

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