{"id":4301,"date":"2025-07-23T14:44:00","date_gmt":"2025-07-23T14:44:00","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/fda-registered-biological-sample-storage-equipment-mve\/"},"modified":"2026-01-09T11:51:06","modified_gmt":"2026-01-09T04:51:06","slug":"fda-registered-binh-nito-long-y-sinh","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/blog\/fda-registered-binh-nito-long-y-sinh\/","title":{"rendered":"\u00dd ngh\u0129a c\u1ee7a \u201cFDA Registered\u201d \u0111\u1ed1i v\u1edbi b\u00ecnh nit\u01a1 l\u1ecfng y sinh"},"content":{"rendered":"<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">FDA c\u00f3 nhi\u1ec1u y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m mu\u1ed1n \u0111\u01b0\u1ee3c x\u00e1c h\u1ecd x\u00e1c minh ch\u1ea5t l\u01b0\u1ee3ng. S\u1ea3n ph\u1ea9m b\u00ecnh nit\u01a1 l\u1ecfng y sinh MVE \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA s\u1ebd c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh, gi\u1ea3m thi\u1ec3u r\u1ee7i ro h\u1ecfng h\u00f3c, \u0111\u1ea3m b\u1ea3o m\u00f4i tr\u01b0\u1eddng l\u01b0u tr\u1eef an to\u00e0n cho m\u1eabu sinh h\u1ecdc l\u00e2m s\u00e0ng.<\/span><\/p>\n<div style=\"width: 612px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" style=\"aspect-ratio: 602\/339;\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/09\/unnamed.png\" alt=\"FDA Registered \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng v\u1edbi b\u00ecnh Nit\u01a1 l\u1ecfng y sinh khi \u1ee9ng d\u1ee5ng trong y t\u1ebf\" width=\"602\" height=\"339\" \/><p class=\"wp-caption-text\"><em>FDA Registered \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng v\u1edbi b\u00ecnh Nit\u01a1 l\u1ecfng y sinh khi \u1ee9ng d\u1ee5ng trong y t\u1ebf<\/em><\/p><\/div>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/fda-registered-binh-nito-long-y-sinh\/#%E2%80%9CFDA_Registered%E2%80%9D_kiem_soat_chat_luong_thiet_bi_y_sinh\" >&#8220;FDA Registered&#8221; ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb y sinh<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/fda-registered-binh-nito-long-y-sinh\/#Phan_biet_%E2%80%9CFDA_Registered%E2%80%9D_voi_%E2%80%9CFDA_Approved%E2%80%9D_va_510k_Clearance\" >Ph\u00e2n bi\u1ec7t &#8220;FDA Registered&#8221; v\u1edbi &#8220;FDA Approved&#8221; v\u00e0 510(k) Clearance<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/fda-registered-binh-nito-long-y-sinh\/#Cac_dong_binh_nito_long_MVE_da_duoc_dang_ky_FDA\" >C\u00e1c d\u00f2ng b\u00ecnh nit\u01a1 l\u1ecfng MVE \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"%E2%80%9CFDA_Registered%E2%80%9D_kiem_soat_chat_luong_thiet_bi_y_sinh\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">&#8220;FDA Registered&#8221; ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb y sinh<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">\u201cFDA Registered\u201d c\u00f3 ngh\u0129a l\u00e0 c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a h\u00e3ng \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u00ednh th\u1ee9c \u0111\u0103ng k\u00fd v\u1edbi C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA). Vi\u1ec7c \u0111\u0103ng k\u00fd n\u00e0y x\u00e1c nh\u1eadn r\u1eb1ng nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a FDA v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m (bao g\u1ed3m b\u00ecnh nit\u01a1 l\u1ecfng l\u01b0u tr\u1eef m\u1eabu) \u0111\u01b0\u1ee3c ch\u1ebf t\u1ea1o, ghi nh\u00e3n v\u00e0 ph\u00e2n ph\u1ed1i theo nh\u1eefng ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n cao nh\u1ea5t. N\u00f3i c\u00e1ch kh\u00e1c, thi\u1ebft b\u1ecb y sinh \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t v\u1ec1 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t.\u00a0<\/span><\/p>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">C\u1ee5 th\u1ec3, c\u00e1c c\u01a1 s\u1edf \u0111\u00e3 \u0111\u0103ng k\u00fd FDA nh\u01b0 c\u1ee7a MVE Biological Solutions ph\u1ea3i tu\u00e2n th\u1ee7 quy ph\u1ea1m Good Manufacturing Practices (GMP \u2013 th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t) v\u00e0 quy \u0111\u1ecbnh h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a FDA (21 CFR Part 820). \u0110i\u1ec1u n\u00e0y bao g\u1ed3m vi\u1ec7c thi\u1ebft l\u1eadp quy tr\u00ecnh s\u1ea3n xu\u1ea5t, ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 t\u00e0i li\u1ec7u ch\u1eb7t ch\u1ebd, duy tr\u00ec h\u1ed3 s\u01a1 l\u00f4 s\u1ea3n xu\u1ea5t, hi\u1ec7u chu\u1ea9n thi\u1ebft b\u1ecb \u0111\u1ecbnh k\u1ef3, v\u1ec7 sinh nh\u00e0 x\u01b0\u1edfng, v\u00e0 \u0111\u00e0o t\u1ea1o nh\u00e2n vi\u00ean theo chu\u1ea9n m\u1ef1c FDA. C\u00e1c y\u00eau c\u1ea7u v\u1ec1 design controls (ki\u1ec3m so\u00e1t thi\u1ebft k\u1ebf) c\u0169ng \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e1p \u1ee9ng ti\u00eau ch\u00ed an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 trong su\u1ed1t v\u00f2ng \u0111\u1eddi s\u1ea3n ph\u1ea9m. Nh\u1edd \u0111\u00f3, s\u1ea3n ph\u1ea9m b\u00ecnh nit\u01a1 l\u1ecfng y sinh \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA s\u1ebd c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh, gi\u1ea3m thi\u1ec3u r\u1ee7i ro h\u1ecfng h\u00f3c, \u0111\u1ea3m b\u1ea3o m\u00f4i tr\u01b0\u1eddng l\u01b0u tr\u1eef an to\u00e0n cho m\u1eabu sinh h\u1ecdc l\u00e2m s\u00e0ng.\u00a0<\/span><\/p>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Vi\u1ec7c m\u1ed9t thi\u1ebft b\u1ecb l\u01b0u tr\u1eef m\u1eabu (nh\u01b0 b\u00ecnh nit\u01a1 l\u1ecfng) \u0111\u01b0\u1ee3c FDA Registered \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng khi \u1ee9ng d\u1ee5ng trong y t\u1ebf. N\u00f3 cho th\u1ea5y nh\u00e0 s\u1ea3n xu\u1ea5t cam k\u1ebft tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n li\u00ean bang v\u1ec1 b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng. Trong l\u0129nh v\u1ef1c l\u01b0u tr\u1eef m\u1eabu l\u00e2m s\u00e0ng \u2013 v\u00ed d\u1ee5 nh\u01b0 l\u01b0u tr\u1eef m\u00e1u, m\u00f4, t\u1ebf b\u00e0o g\u1ed1c, ph\u00f4i IVF \u2013 \u0111\u1ed9 tin c\u1eady c\u1ee7a thi\u1ebft b\u1ecb c\u00f3 \u00fd ngh\u0129a s\u1ed1ng c\u00f2n. M\u1ed9t b\u00ecnh nit\u01a1 l\u1ecfng \u0111\u1ea1t chu\u1ea9n \u0111\u0103ng k\u00fd FDA \u0111\u1ed3ng ngh\u0129a v\u1edbi vi\u1ec7c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t d\u01b0\u1edbi s\u1ef1 gi\u00e1m s\u00e1t theo quy \u0111\u1ecbnh, gi\u00fap c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m, ng\u00e2n h\u00e0ng sinh h\u1ecdc v\u00e0 trung t\u00e2m y t\u1ebf y\u00ean t\u00e2m h\u01a1n v\u1ec1 \u0111\u1ed9 an to\u00e0n khi s\u1eed d\u1ee5ng tr\u1ef1c ti\u1ebfp cho m\u1ee5c \u0111\u00edch y t\u1ebf. Th\u1ef1c t\u1ebf, MVE Biological Solutions hi\u1ec7n l\u00e0 h\u00e3ng s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb l\u01b0u tr\u1eef l\u1ea1nh s\u00e2u duy nh\u1ea5t \u0111\u1ea1t \u0111\u0103ng k\u00fd FDA, cung c\u1ea5p c\u00e1c gi\u1ea3i ph\u00e1p \u0111\u00f4ng l\u1ea1nh \u0111\u00e1p \u1ee9ng nh\u1eefng ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd cao nh\u1ea5t v\u00e0 \u0111\u1ea3m b\u1ea3o an to\u00e0n cho m\u1eabu sinh h\u1ecdc qu\u00fd gi\u00e1 c\u1ee7a kh\u00e1ch h\u00e0ng.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Phan_biet_%E2%80%9CFDA_Registered%E2%80%9D_voi_%E2%80%9CFDA_Approved%E2%80%9D_va_510k_Clearance\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">Ph\u00e2n bi\u1ec7t &#8220;FDA Registered&#8221; v\u1edbi &#8220;FDA Approved&#8221; v\u00e0 510(k) Clearance<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Thu\u1eadt ng\u1eef \u201cFDA Registered\u201d kh\u00e1c bi\u1ec7t r\u00f5 r\u1ec7t v\u1edbi \u201cFDA Approved\u201d ho\u1eb7c \u201c510(k) cleared\u201d (ch\u1ea5p thu\u1eadn 510(k)). Vi\u1ec7c \u0111\u0103ng k\u00fd FDA th\u1ef1c ch\u1ea5t ch\u1ec9 c\u00f3 ngh\u0129a l\u00e0 c\u00f4ng ty ho\u1eb7c s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd v\u00e0 li\u1ec7t k\u00ea trong c\u01a1 s\u1edf d\u1eef li\u1ec7u c\u1ee7a FDA, \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd \u0111\u1ec3 l\u01b0u h\u00e0nh, nh\u01b0ng kh\u00f4ng \u0111\u1ed3ng ngh\u0129a r\u1eb1ng FDA \u0111\u00e3 \u0111\u00e1nh gi\u00e1 hay ch\u1ee9ng nh\u1eadn an to\u00e0n\/hi\u1ec7u qu\u1ea3 cho s\u1ea3n ph\u1ea9m \u0111\u00f3. Theo FDA, khi m\u1ed9t c\u01a1 s\u1edf \u0111\u0103ng k\u00fd v\u00e0 li\u1ec7t k\u00ea thi\u1ebft b\u1ecb, \u201cm\u1ee5c ghi trong c\u01a1 s\u1edf d\u1eef li\u1ec7u \u0111\u0103ng k\u00fd c\u1ee7a FDA kh\u00f4ng ph\u1ea3i l\u00e0 s\u1ef1 ph\u00ea duy\u1ec7t, ch\u1ea5p thu\u1eadn hay cho ph\u00e9p c\u1ee7a FDA \u0111\u1ed1i v\u1edbi c\u01a1 s\u1edf ho\u1eb7c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3\u201d. N\u00f3i c\u00e1ch kh\u00e1c, FDA kh\u00f4ng \u201cph\u00ea duy\u1ec7t\u201d vi\u1ec7c \u0111\u0103ng k\u00fd \u2013 \u0111\u0103ng k\u00fd ch\u1ec9 l\u00e0 th\u1ee7 t\u1ee5c \u0111\u1ec3 FDA bi\u1ebft \u0111\u1ebfn c\u01a1 s\u1edf v\u00e0 c\u00e1c lo\u1ea1i thi\u1ebft b\u1ecb m\u00e0 h\u1ecd s\u1ea3n xu\u1ea5t.\u00a0<\/span><\/p>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Ng\u01b0\u1ee3c l\u1ea1i, \u201cFDA Approved\u201d \u00e1p d\u1ee5ng cho c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u00f2i h\u1ecfi FDA \u0111\u00e1nh gi\u00e1 v\u00e0 ph\u00ea duy\u1ec7t ti\u1ec1n th\u1ecb tr\u01b0\u1eddng, th\u01b0\u1eddng l\u00e0 thu\u1ed1c ho\u1eb7c c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf nh\u00f3m r\u1ee7i ro cao (Class III). M\u1ed9t thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t ngh\u0129a l\u00e0 \u0111\u00e3 tr\u1ea3i qua th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng nghi\u00eam ng\u1eb7t v\u00e0 FDA x\u00e1c nh\u1eadn t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 tr\u01b0\u1edbc khi cho ph\u00e9p l\u01b0u h\u00e0nh. C\u00f2n 510(k) clearance l\u00e0 quy tr\u00ecnh \u0111\u1ec3 FDA \u201cch\u1ea5p thu\u1eadn t\u01b0\u01a1ng \u0111\u01b0\u01a1ng\u201d cho c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf nh\u00f3m trung b\u00ecnh (Class II) \u2013 nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i ch\u1ee9ng minh thi\u1ebft b\u1ecb m\u1edbi t\u01b0\u01a1ng \u0111\u01b0\u01a1ng an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 v\u1edbi m\u1ed9t thi\u1ebft b\u1ecb \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh h\u1ee3p ph\u00e1p tr\u01b0\u1edbc \u0111\u00f3 (predicate device). Ch\u1ec9 khi FDA xem x\u00e9t h\u1ed3 s\u01a1 510(k) v\u00e0 ra th\u01b0 ch\u1ea5p thu\u1eadn, s\u1ea3n ph\u1ea9m m\u1edbi \u0111\u01b0\u1ee3c coi l\u00e0 \u201cFDA-cleared\u201d.\u00a0<\/span><\/p>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Trong b\u1ed1i c\u1ea3nh b\u00ecnh nit\u01a1 l\u1ecfng l\u01b0u tr\u1eef m\u1eabu, c\u00e1c thi\u1ebft b\u1ecb n\u00e0y th\u01b0\u1eddng thu\u1ed9c nh\u00f3m r\u1ee7i ro th\u1ea5p ho\u1eb7c trung b\u00ecnh (v\u00ed d\u1ee5: thi\u1ebft b\u1ecb l\u01b0u tr\u1eef m\u00f4\/t\u1ebf b\u00e0o) v\u00e0 nhi\u1ec1u tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c mi\u1ec5n tr\u1eeb y\u00eau c\u1ea7u 510(k). Do \u0111\u00f3, vi\u1ec7c \u0111\u0103ng k\u00fd v\u00e0 li\u1ec7t k\u00ea v\u1edbi FDA l\u00e0 \u0111\u1ee7 \u0111\u1ec3 h\u1ee3p ph\u00e1p h\u00f3a l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m. MVE Biological Solutions kh\u1eb3ng \u0111\u1ecbnh vi\u1ec7c \u0111\u0103ng k\u00fd FDA cho th\u1ea5y tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh, nh\u01b0ng kh\u00f4ng ng\u1ee5 \u00fd r\u1eb1ng s\u1ea3n ph\u1ea9m c\u1ee7a h\u1ecd \u0111\u00e3 \u0111\u01b0\u1ee3c FDA \u201cph\u00ea duy\u1ec7t\u201d hay \u201cch\u1ee9ng nh\u1eadn\u201d th\u00f4ng qua quy tr\u00ecnh \u0111\u00e1nh gi\u00e1 ti\u1ec1n th\u1ecb tr\u01b0\u1eddng. T\u00f3m l\u1ea1i, FDA Registered ch\u1ee7 y\u1ebfu li\u00ean quan \u0111\u1ebfn tu\u00e2n th\u1ee7 quy tr\u00ecnh v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n xu\u1ea5t, trong khi FDA Cleared\/FDA Approved li\u00ean quan \u0111\u1ebfn \u0111\u00e1nh gi\u00e1 tr\u1ef1c ti\u1ebfp c\u1ee7a FDA v\u1ec1 thi\u1ebft b\u1ecb tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Cac_dong_binh_nito_long_MVE_da_duoc_dang_ky_FDA\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">C\u00e1c d\u00f2ng b\u00ecnh nit\u01a1 l\u1ecfng MVE \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE Biological Solutions cung c\u1ea5p d\u1ea3i s\u1ea3n ph\u1ea9m \u0111a d\u1ea1ng, t\u1eeb c\u00e1c t\u1ee7 \u0111\u00f4ng l\u1ea1nh dung t\u00edch l\u1edbn cho \u0111\u1ebfn b\u00ecnh nit\u01a1 di \u0111\u1ed9ng, \u0111\u00e1p \u1ee9ng m\u1ecdi quy m\u00f4 l\u01b0u tr\u1eef v\u00e0 v\u1eadn chuy\u1ec3n m\u1eabu. D\u01b0\u1edbi \u0111\u00e2y l\u00e0 nh\u1eefng d\u00f2ng s\u1ea3n ph\u1ea9m ti\u00eau bi\u1ec3u c\u00f9ng \u1ee9ng d\u1ee5ng th\u1ef1c t\u1ebf v\u00e0 \u01b0u \u0111i\u1ec3m n\u1ed5i b\u1eadt.<\/span><\/p>\n<div style=\"width: 1930px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" style=\"aspect-ratio: 1920\/1080;\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/09\/CryoSystem-6000FA-1.jpg\" alt=\"MVE CryoSystem Series \u2013 B\u00ecnh nit\u01a1 nh\u00f4m g\u1ecdn nh\u1eb9, kinh t\u1ebf cho ph\u00f2ng lab\" width=\"1920\" height=\"1080\" \/><p class=\"wp-caption-text\"><em>MVE CryoSystem Series \u2013 B\u00ecnh nit\u01a1 nh\u00f4m g\u1ecdn nh\u1eb9 cho ph\u00f2ng lab<\/em><\/p><\/div>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">C\u00e1c thi\u1ebft b\u1ecb cryogenic c\u1ee7a MVE \u0111\u01b0\u1ee3c \u1ee9ng d\u1ee5ng r\u1ed9ng r\u00e3i t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng sinh h\u1ecdc, c\u01a1 s\u1edf IVF, ph\u00f2ng th\u00ed nghi\u1ec7m l\u00e2m s\u00e0ng v\u00e0 b\u1ec7nh vi\u1ec7n \u0111\u1ec3 b\u1ea3o qu\u1ea3n t\u1ebf b\u00e0o, m\u00f4, huy\u1ebft t\u01b0\u01a1ng, ph\u00f4i \u1edf nhi\u1ec7t \u0111\u1ed9 c\u1ef1c th\u1ea5p. Sau khi \u0111\u0103ng k\u00fd v\u1edbi FDA, t\u1ea5t c\u1ea3 c\u00e1c t\u1ee7 \u0111\u00f4ng v\u00e0 b\u00ecnh ch\u1ee9a nit\u01a1 l\u1ecfng li\u00ean quan c\u1ee7a MVE \u0111\u00e3 \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea ch\u00ednh th\u1ee9c trong c\u01a1 s\u1edf d\u1eef li\u1ec7u thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a FDA, \u0111\u1ed3ng ngh\u0129a v\u1edbi vi\u1ec7c ch\u00fang \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng nghi\u00eam ng\u1eb7t (v\u00ed d\u1ee5: tu\u00e2n th\u1ee7 GMP v\u00e0 21 CFR Part 820) trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t. D\u01b0\u1edbi \u0111\u00e2y l\u00e0 m\u1ed9t s\u1ed1 d\u00f2ng s\u1ea3n ph\u1ea9m b\u00ecnh nit\u01a1 l\u1ecfng v\u00e0 t\u1ee7 \u0111\u00f4ng cryo c\u1ee7a MVE hi\u1ec7n \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA, ph\u1ee5c v\u1ee5 cho l\u01b0u tr\u1eef m\u1eabu ng\u01b0\u1eddi trong y h\u1ecdc, IVF, ch\u1ea9n \u0111o\u00e1n v\u00e0 l\u01b0u tr\u1eef sinh h\u1ecdc:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE HEco\u2122 Series.\u00a0<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE CryoSystem Series.\u00a0<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE Stock Series.\u00a0<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE SC &amp; XC Series.\u00a0<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE Vapor Shipper Series.\u00a0<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE Doble Series.\u00a0<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">MVE Blood Bag Shippers.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">C\u00e1c thi\u1ebft b\u1ecb k\u1ec3 tr\u00ean \u0111\u1ec1u \u0111\u00e3 \u0111\u01b0\u1ee3c MVE \u0111\u0103ng k\u00fd v\u00e0 li\u1ec7t k\u00ea v\u1edbi FDA trong n\u0103m 2025. Vi\u1ec7c c\u00f3 t\u00ean trong danh s\u00e1ch c\u1ee7a FDA kh\u1eb3ng \u0111\u1ecbnh r\u1eb1ng t\u1eeb kh\u00e2u thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t \u0111\u1ebfn ki\u1ec3m tra xu\u1ea5t x\u01b0\u1edfng c\u1ee7a nh\u1eefng b\u00ecnh nit\u01a1 l\u1ecfng n\u00e0y \u0111\u1ec1u tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng nghi\u00eam ng\u1eb7t trong ng\u00e0nh y t\u1ebf. \u0110\u1ed1i v\u1edbi c\u00e1c \u1ee9ng d\u1ee5ng l\u01b0u tr\u1eef m\u1eabu ng\u01b0\u1eddi (t\u1ebf b\u00e0o, m\u00f4, m\u00e1u, ph\u00f4i\u2026) ph\u1ee5c v\u1ee5 ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb hay h\u1ed7 tr\u1ee3 sinh s\u1ea3n, ch\u1ee9ng nh\u1eadn \u201cFDA Registered\u201d n\u00e0y l\u00e0 m\u1ed9t d\u1ea5u hi\u1ec7u \u0111\u1ea3m b\u1ea3o v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m, gi\u00fap ng\u01b0\u1eddi d\u00f9ng cu\u1ed1i (c\u00e1c ph\u00f2ng lab l\u00e2m s\u00e0ng, trung t\u00e2m IVF, ng\u00e2n h\u00e0ng sinh h\u1ecdc) th\u00eam tin t\u01b0\u1edfng khi s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb tr\u1ef1c ti\u1ebfp li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe con ng\u01b0\u1eddi.<\/span><\/p>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">V\u1edbi s\u1ef1 \u0111\u1ea3m b\u1ea3o c\u1ee7a \u201cFDA Registered\u201d b\u00ecnh nit\u01a1 l\u1ecfng MVE Biological Solutions \u0111\u1ea3m b\u1ea3o mang \u0111\u1ebfn gi\u1ea3i ph\u00e1p l\u01b0u tr\u1eef m\u1eabu sinh h\u1ecdc an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3. H\u00e3y li\u00ean h\u1ec7 ngay v\u1edbi chuy\u00ean gia Biogroup \u0111\u1ec3 nh\u1eadn t\u01b0 v\u1ea5n chi ti\u1ebft h\u01a1n v\u1ec1 s\u1ea3n ph\u1ea9m.<\/span><\/p>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 13.999999999999998pt;\">\ud83d\udce9\u00a0<strong>Th\u00f4ng tin li\u00ean h\u1ec7:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Website: <a href=\"https:\/\/biogroupvietnam.com\/vi\/lien-he\/\">https:\/\/biogroupvietnam.com\/vi\/lien-he\/<\/a><\/span><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Hotline: +84 963 621 421<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Email: <a href=\"mailto:info@biogroupvietnam.com\">info@biogroupvietnam.com\u00a0<\/a><\/span><\/li>\n<\/ul>\n<p><a href=\"https:\/\/biogroupvietnam.com\/vi\/danh-muc-san-pham\/bao-quan-lanh-te-bao\/\">T\u00ecm hi\u1ec3u th\u00eam s\u1ea3n ph\u1ea9m b\u1ea3o qu\u1ea3n l\u1ea1nh t\u1ebf b\u00e0o t\u1eeb MVE Biological Solutions<\/a><\/p>\n<p><strong>T\u00c0I LI\u1ec6U THAM KH\u1ea2O<\/strong><\/p>\n<ol>\n<li><em><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">FDA. (n.d.).\u00a0S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa kh\u00e1i ni\u1ec7m \u0111\u0103ng k\u00fd v\u00e0 ph\u00ea duy\u1ec7t thi\u1ebft b\u1ecb y t\u1ebf. U.S. Food and Drug Administration. Truy c\u1eadp t\u1eeb <a href=\"https:\/\/www.fda.gov\">https:\/\/www.fda.gov<\/a><\/span><\/em><\/li>\n<li><em><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">MVE Biological Solutions. (n.d.).\u00a0Th\u00f4ng tin v\u1ec1 vi\u1ec7c tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh v\u00e0 danh m\u1ee5c s\u1ea3n ph\u1ea9m cryogenic \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA. Truy c\u1eadp t\u1eeb <a href=\"https:\/\/www.mvebio.com\">https:\/\/www.mvebio.com<\/a><\/span><\/em><\/li>\n<li><em><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Cryoport Inc. (n.d.).\u00a0S\u1ea3n ph\u1ea9m cryogenic \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA c\u1ee7a Cryoport Inc. Truy c\u1eadp t\u1eeb <a href=\"https:\/\/www.ir.cryoportinc.com\">https:\/\/www.ir.cryoportinc.com<\/a><\/span><\/em><\/li>\n<li><em><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">MVE Biological Solutions. (n.d.).\u00a0C\u00e1c d\u00f2ng s\u1ea3n ph\u1ea9m cryogenic v\u00e0 \u1ee9ng d\u1ee5ng trong y sinh. Truy c\u1eadp t\u1eeb <a href=\"https:\/\/www.mvebio.com\">https:\/\/www.mvebio.com<\/a><\/span><\/em><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>FDA c\u00f3 nhi\u1ec1u y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m mu\u1ed1n \u0111\u01b0\u1ee3c x\u00e1c h\u1ecd x\u00e1c minh ch\u1ea5t l\u01b0\u1ee3ng. S\u1ea3n ph\u1ea9m b\u00ecnh nit\u01a1 l\u1ecfng y sinh MVE \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd FDA s\u1ebd c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh, gi\u1ea3m thi\u1ec3u r\u1ee7i ro h\u1ecfng h\u00f3c, \u0111\u1ea3m b\u1ea3o m\u00f4i tr\u01b0\u1eddng l\u01b0u tr\u1eef an to\u00e0n<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/fda-registered-binh-nito-long-y-sinh\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":6427,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4301","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u00dd ngh\u0129a c\u1ee7a \u201cFDA Registered\u201d \u0111\u1ed1i v\u1edbi b\u00ecnh nit\u01a1 l\u1ecfng y sinh<\/title>\n<meta name=\"description\" content=\"B\u00ecnh nit\u01a1 l\u1ecfng chu\u1ea9n FDA c\u1ee7a MVE tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u s\u1ea3n xu\u1ea5t nghi\u00eam ng\u1eb7t, \u0111\u1ea3m b\u1ea3o an to\u00e0n sinh h\u1ecdc cao. Hi\u1ec3u s\u00e2u \u00fd ngh\u0129a v\u1edbi FDA Registered, GMP v\u00e0 l\u00fd do c\u00e1c chuy\u00ean gia tin d\u00f9ng thi\u1ebft b\u1ecb t\u1eeb MVE Biological Solutions.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/fda-registered-binh-nito-long-y-sinh\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00dd ngh\u0129a c\u1ee7a \u201cFDA Registered\u201d \u0111\u1ed1i v\u1edbi b\u00ecnh nit\u01a1 l\u1ecfng y sinh\" \/>\n<meta property=\"og:description\" content=\"B\u00ecnh nit\u01a1 l\u1ecfng chu\u1ea9n FDA c\u1ee7a MVE tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u s\u1ea3n xu\u1ea5t nghi\u00eam ng\u1eb7t, \u0111\u1ea3m b\u1ea3o an to\u00e0n sinh h\u1ecdc cao. 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