Dispositivos MédicosAtivo

HDL SD

10009010340

Informações Gerais

Nome do produto

HDL SD

Número de registro

10009010340

Nome técnico

LIPOPROTEÍNA DE ALTA DENSIDADE (HDL)

Classe de risco

Processo

25351649743201780

Empresa Detentora

Razão social

LABTEST DIAGNOSTICA S/A

CNPJ

16.516.296/0001-38

Fabricante

LABTEST DIAGNOSTICA S/A

País de fabricação

BRASIL

Registro

Situação

Ativo

Vencimento

Registro vigente

Registro de prazo indeterminado

Histórico de Situação

VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(220)

R1: 1 x 105 mL, R2: 1 x 35 mL, CAL: 1 x 1 mL
R1: 1 x 120 mL, R2: 1 x 40 mL, CAL:1 x 1 mL
R1: 1 x 135 mL, R2: 1 x 45 mL, CAL:1 x 1 mL
R1: 1 x 15 mL, R2: 1 x 5 mL, CAL: 1 x 1 mL
R1: 1 x 150 mL, R2: 1 x 50 mL, CAL:1 x 1 mL
R1: 1 x 165 mL, R2: 1 x 55 mL, CAL:1 x 1 mL
R1: 1 x 180 mL, R2: 1 x 60 mL, CAL:1 x 1 mL
R1: 1 x 195 mL, R2: 1 x 65 mL, CAL:1 x 1 mL
R1: 1 x 21 mL, R2: 1 x 7 mL, CAL: 1 x 1 mL
R1: 1 x 210 mL, R2: 1 x 70 mL, CAL:1 x 1 mL
R1: 1 x 225 mL, R2: 1 x 75 mL, CAL:1 x 1 mL
R1: 1 x 240 mL, R2: 1 x 80 mL, CAL:1 x 1 mL
R1: 1 x 255 mL, R2: 1 x 85 mL, CAL:1 x 1 mL
R1: 1 x 270 mL, R2: 1 x 90 mL, CAL:1 x 1 mL
R1: 1 x 28 mL, R2: 1 x 10 mL, CAL:1 x 1 mL
R1: 1 x 30 mL, R2: 1 x 10 mL, CAL: 1 x 1 mL
R1: 1 x 300 mL, R2: 1 x 100 mL, CAL:1 x 1 mL
R1: 1 x 41 mL, R2: 1 x 15 mL, CAL:1 x 1 mL
R1: 1 x 42 mL, R2: 1 x 14 mL, CAL: 1 x 1 mL
R1: 1 x 60 mL, R2: 1 x 20 mL, CAL: 1 x 1 mL
R1: 1 x 75 mL, R2: 1 x 25 mL, CAL: 1 x 1 mL
R1: 1 x 90 mL, R2: 1 x 30 mL, CAL: 1 x 1 mL
R1: 10 x 105 mL, R2: 10 x 35 mL, CAL: 1 x 1 mL
R1: 10 x 120 mL, R2: 10 x 40 mL, CAL:1 x 1 mL
R1: 10 x 135 mL, R2: 10 x 45 mL, CAL: 1 x 1 mL
R1: 10 x 15 mL, R2: 10 x 5 mL, CAL: 1 x 1 mL
R1: 10 x 150 mL, R2: 10 x 50 mL, CAL:1 x 1 mL
R1: 10 x 165 mL, R2: 10 x 55 mL, CAL: 1 x 1 mL
R1: 10 x 180 mL, R2: 10 x 60 mL, CAL:1 x 1 mL
R1: 10 x 195 mL, R2: 10 x 65 mL, CAL:1 x 1 mL
R1: 10 x 21 mL, R2: 10 x 7 mL, CAL: 1 x 1 mL
R1: 10 x 210 mL, R2: 10 x 70 mL, CAL:1 x 1 mL
R1: 10 x 225 mL, R2: 10 x 75 mL, CAL:1 x 1 mL
R1: 10 x 240 mL, R2: 10 x 80 mL, CAL:1 x 1 mL
R1: 10 x 255 mL, R2: 10 x 85 mL, CAL:1 x 1 mL
R1: 10 x 270 mL, R2: 10 x 90 mL, CAL:1 x 1 mL
R1: 10 x 28 mL, R2: 10 x 10 mL, CAL:1 x 1 mL
R1: 10 x 30 mL, R2: 10 x 10 mL, CAL: 1 x 1 mL
R1: 10 x 300 mL, R2: 10 x 100 mL, CAL:1 x 1 mL
R1: 10 x 41 mL, R2: 10 x 15 mL, CAL:1 x 1 mL
R1: 10 x 42 mL, R2: 10 x 14 mL, CAL: 1 x 1 mL
R1: 10 x 60 mL, R2: 10 x 20 mL, CAL: 1 x 1 mL
R1: 10 x 75 mL, R2: 10 x 25 mL, CAL: 1 x 1 mL
R1: 10 x 90 mL, R2: 10 x 30 mL, CAL: 1 x 1 mL
R1: 2 x 105 mL, R2: 2 x 35 mL, CAL: 1 x 1 mL
R1: 2 x 120 mL, R2: 2 x 40 mL, CAL:1 x 1 mL
R1: 2 x 135 mL, R2: 2 x 45 mL, CAL:1 x 1 mL
R1: 2 x 15 mL, R2: 2 x 5 mL, CAL:1 x 1 mL
R1: 2 x 150 mL, R2: 2 x 50 mL, CAL:1 x 1 mL
R1: 2 x 165 mL, R2: 2 x 55 mL, CAL:1 x 1 mL
R1: 2 x 180 mL, R2:2 x 60 mL, CAL:1 x 1 mL
R1: 2 x 195 mL, R2: 2 x 65 mL, CAL:1 x 1 mL
R1: 2 x 21 mL, R2: 2 x 7 mL, CAL: 1 x 1 mL
R1: 2 x 210 mL, R2: 2 x 70 mL, CAL:1 x 1 mL
R1: 2 x 225 mL, R2: 2 x 75 mL, CAL:1 x 1 mL
R1: 2 x 240 mL, R2: 2 x 80 mL, CAL:1 x 1 mL
R1: 2 x 255 mL, R2: 2 x 85 mL, CAL:1 x 1 mL
R1: 2 x 270 mL, R2: 2 x 90 mL, CAL:1 x 1 mL
R1: 2 x 28 mL, R2: 2 x 10 mL, CAL:1 x 1 mL
R1: 2 x 30 mL, R2: 2 x 10 mL, CAL: 1 x 1 mL
R1: 2 x 300 mL, R2: 2 x 100 mL, CAL:1 x 1 mL
R1: 2 x 41 mL, R2: 2 x 15 mL, CAL:1 x 1 mL
R1: 2 x 42 mL, R2: 2 x 14 mL, CAL: 1 x 1 mL
R1: 2 x 60 mL, R2: 2 x 20 mL, CAL: 1 x 1 mL
R1: 2 x 75 mL, R2: 2 x 25 mL, CAL: 1 x 1 mL
R1: 2 x 90 mL, R2: 2 x 30 mL, CAL: 1 x 1 mL
R1: 3 x 105 mL, R2: 3 x 35 mL, CAL: 1 x 1 mL
R1: 3 x 120 mL, R2: 3 x 40 mL, CAL:1 x 1 mL
R1: 3 x 135 mL, R2: 3 x 45 mL, CAL:1 x 1 mL
R1: 3 x 15 mL, R2: 3 x 5 mL, CAL: 1 x 1 mL
R1: 3 x 150 mL, R2: 3 x 50 mL, CAL:1 x 1 mL
R1: 3 x 165 mL, R2: 3 x 55 mL, CAL:1 x 1 mL
R1: 3 x 180 mL, R2: 3 x 60 mL, CAL:1 x 1 mL
R1: 3 x 195 mL, R2: 3 x 65 mL, CAL:1 x 1 mL
R1: 3 x 21 mL, R2: 3 x 7 mL, CAL: 1 x 1 mL
R1: 3 x 210 mL, R2: 3 x 70 mL, CAL:1 x 1 mL
R1: 3 x 225 mL, R2: 3 x 75 mL, CAL:1 x 1 mL
R1: 3 x 240 mL, R2: 3 x 80 mL, CAL:1 x 1 mL
R1: 3 x 255 mL, R2: 3 x 85 mL, CAL:1 x 1 mL
R1: 3 x 270 mL, R2: 3 x 90 mL, CAL:1 x 1 mL
R1: 3 x 28 mL, R2: 3 x 10 mL, CAL:1 x 1 mL
R1: 3 x 30 mL, R2: 3 x 10 mL, CAL: 1 x 1 mL
R1: 3 x 300 mL, R2: 3 x 100 mL, CAL:1 x 1 mL
R1: 3 x 41 mL, R2: 3 x 15 mL, CAL:1 x 1 mL
R1: 3 x 42 mL, R2: 3 x 14 mL, CAL: 1 x 1 mL
R1: 3 x 60 mL, R2: 3 x 20 mL, CAL: 1 x 1 mL
R1: 3 x 75 mL, R2: 3 x 25 mL, CAL: 1 x 1 mL
R1: 3 x 90 mL, R2: 3 x 30 mL, CAL: 1 x 1 mL
R1: 4 x 105 mL, R2: 4 x 35 mL, CAL: 1 x 1 mL
R1: 4 x 120 mL, R2: 4 x 40 mL, CAL:1 x 1 mL
R1: 4 x 135 mL, R2: 4 x 45 mL, CAL:1 x 1 mL
R1: 4 x 15 mL, R2: 4 x 5 mL, CAL: 1 x 1 mL
R1: 4 x 150 mL, R2: 4 x 50 mL, CAL:1 x 1 mL
R1: 4 x 165 mL, R2: 4 x 55 mL, CAL:1 x 1 mL
R1: 4 x 180 mL, R2: 4 x 60 mL, CAL:1 x 1 mL
R1: 4 x 195 mL, R2: 4 x 65 mL, CAL:1 x 1 mL
R1: 4 x 21 mL, R2: 4 x 7 mL, CAL: 1 x 1 mL
R1: 4 x 210 mL, R2: 4 x 70 mL, CAL:1 x 1 mL
R1: 4 x 225 mL, R2: 4 x 75 mL, CAL:1 x 1 mL
R1: 4 x 240 mL, R2: 4 x 80 mL, CAL:1 x 1 mL
R1: 4 x 255 mL, R2: 4 x 85 mL, CAL:1 x 1 mL
R1: 4 x 270 mL, R2: 4 x 90 mL, CAL:1 x 1 mL
R1: 4 x 28 mL, R2: 4 x 10 mL, CAL:1 x 1 mL
R1: 4 x 30 mL, R2: 4 x 10 mL, CAL: 1 x 1 mL
R1: 4 x 300 mL, R2: 4 x 100 mL, CAL:1 x 1 mL
R1: 4 x 41 mL, R2: 4 x 15 mL, CAL:1 x 1 mL
R1: 4 x 42 mL, R2: 4 x 14 mL, CAL: 1 x 1 mL
R1: 4 x 60 mL, R2: 4 x 20 mL, CAL: 1 x 1 mL
R1: 4 x 75 mL, R2: 4 x 25 mL, CAL: 1 x 1 mL
R1: 4 x 90 mL, R2: 4 x 30 mL, CAL: 1 x 1 mL
R1: 5 x 105 mL, R2: 5 x 35 mL, CAL: 1 x 1 mL
R1: 5 x 120 mL, R2: 5 x 40 mL, CAL:1 x 1 mL
R1: 5 x 135 mL, R2: 5 x 45 mL, CAL:1 x 1 mL
R1: 5 x 15 mL, R2: 5 x 5 mL, CAL: 1 x 1 mL
R1: 5 x 150 mL, R2: 5 x 50 mL, CAL:1 x 1 mL
R1: 5 x 165 mL, R2: 5 x 55 mL, CAL:1 x 1 mL
R1: 5 x 180 mL, R2: 5 x 60 mL, CAL:1 x 1 mL
R1: 5 x 195 mL, R2: 5 x 65 mL, CAL:1 x 1 mL
R1: 5 x 21 mL, R2: 5 x 7 mL, CAL: 1 x 1 mL
R1: 5 x 210 mL, R2: 5 x 70 mL, CAL:1 x 1 mL
R1: 5 x 225 mL, R2: 5 x 75 mL, CAL:1 x 1 mL
R1: 5 x 240 mL, R2: 5 x 80 mL, CAL:1 x 1 mL
R1: 5 x 255 mL, R2: 5 x 85 mL, CAL:1 x 1 mL
R1: 5 x 270 mL, R2: 5 x 90 mL, CAL:1 x 1 mL
R1: 5 x 28 mL, R2: 5 x 10 mL, CAL:1 x 1 mL
R1: 5 x 30 mL, R2: 5 x 10 mL, CAL: 1 x 1 mL
R1: 5 x 300 mL, R2: 5 x 100 mL, CAL:1 x 1 mL
R1: 5 x 41 mL, R2: 5 x 15 mL, CAL:1 x 1 mL
R1: 5 x 42 mL, R2: 5 x 14 mL, CAL: 1 x 1 mL
R1: 5 x 60 mL, R2: 5 x 20 mL, CAL: 1 x 1 mL
R1: 5 x 75 mL, R2: 5 x 25 mL, CAL: 1 x 1 mL
R1: 5 x 90 mL, R2: 5 x 30 mL, CAL: 1 x 1 mL
R1: 6 x 105 mL, R2: 6 x 35 mL, CAL: 1 x 1 mL
R1: 6 x 120 mL, R2: 6 x 40 mL, CAL:1 x 1 mL
R1: 6 x 135 mL, R2: 6 x 45 mL, CAL:1 x 1 mL
R1: 6 x 15 mL, R2: 6 x 5 mL, CAL: 1 x 1 mL
R1: 6 x 150 mL, R2: 6 x 50 mL, CAL:1 x 1 mL
R1: 6 x 165 mL, R2: 6 x 55 mL, CAL:1 x 1 mL
R1: 6 x 180 mL, R2: 6 x 60 mL, CAL:1 x 1 mL
R1: 6 x 195 mL, R2: 6 x 65 mL, CAL:1 x 1 mL
R1: 6 x 21 mL, R2: 6 x 7 mL, CAL: 1 x 1 mL
R1: 6 x 210 mL, R2: 6 x 70 mL, CAL:1 x 1 mL
R1: 6 x 225 mL, R2: 6 x 75 mL, CAL:1 x 1 mL
R1: 6 x 240 mL, R2: 6 x 80 mL, CAL:1 x 1 mL
R1: 6 x 255 mL, R2: 6 x 85 mL, CAL:1 x 1 mL
R1: 6 x 270 mL, R2: 6 x 90 mL, CAL:1 x 1 mL
R1: 6 x 28 mL, R2: 6 x 10 mL, CAL:1 x 1 mL
R1: 6 x 30 mL, R2: 6 x 10 mL, CAL: 1 x 1 mL
R1: 6 x 300 mL, R2: 6 x 100 mL, CAL:1 x 1 mL
R1: 6 x 41 mL, R2: 6 x 15 mL, CAL:1 x 1 mL
R1: 6 x 42 mL, R2: 6 x 14 mL, CAL: 1 x 1 mL
R1: 6 x 60 mL, R2: 6 x 20 mL, CAL: 1 x 1 mL
R1: 6 x 75 mL, R2: 6 x 25 mL, CAL: 1 x 1 mL
R1: 6 x 90 mL, R2: 6 x 30 mL, CAL: 1 x 1 mL
R1: 7 x 105 mL, R2: 7 x 35 mL, CAL: 1 x 1 mL
R1: 7 x 120 mL, R2: 7 x 40 mL, CAL:1 x 1 mL
R1: 7 x 135 mL, R2: 7 x 45 mL, CAL:1 x 1 mL
R1: 7 x 15 mL, R2: 7 x 5 mL, CAL: 1 x 1 mL
R1: 7 x 150 mL, R2: 7 x 50 mL, CAL:1 x 1 mL
R1: 7 x 165 mL, R2: 7 x 55 mL, CAL:1 x 1 mL
R1: 7 x 180 mL, R2: 7 x 60 mL, CAL:1 x 1 mL
R1: 7 x 195 mL, R2: 7 x 65 mL, CAL:1 x 1 mL
R1: 7 x 21 mL, R2: 7 x 7 mL, CAL: 1 x 1 mL
R1: 7 x 210 mL, R2: 7 x 70 mL, CAL:1 x 1 mL
R1: 7 x 225 mL, R2: 7 x 75 mL, CAL:1 x 1 mL
R1: 7 x 240 mL, R2: 7 x 80 mL, CAL:1 x 1 mL
R1: 7 x 255 mL, R2: 7 x 85 mL, CAL:1 x 1 mL
R1: 7 x 270 mL, R2: 7 x 90 mL, CAL:1 x 1 mL
R1: 7 x 28 mL, R2: 7 x 10 mL, CAL:1 x 1 mL
R1: 7 x 30 mL, R2: 7 x 10 mL, CAL: 1 x 1 mL
R1: 7 x 300 mL, R2: 7 x 100 mL, CAL:1 x 1 mL
R1: 7 x 41 mL, R2: 7 x 15 mL, CAL:1 x 1 mL
R1: 7 x 42 mL, R2: 7 x 14 mL, CAL: 1 x 1 mL
R1: 7 x 60 mL, R2: 7 x 20 mL, CAL: 1 x 1 mL
R1: 7 x 75 mL, R2: 7 x 25 mL, CAL: 1 x 1 mL
R1: 7 x 90 mL, R2: 7 x 30 mL, CAL: 1 x 1 mL
R1: 8 x 105 mL , R2: 8 x 35 mL, CAL:1 x 1 mL
R1: 8 x 120 mL, R2: 8 x 40 mL, CAL:1 x 1 mL
R1: 8 x 135 mL, R2: 8 x 45 mL, CAL:1 x 1 mL
R1: 8 x 15 mL, R2: 8 x 5 mL, CAL: 1 x 1 mL
R1: 8 x 150 mL, R2: 8 x 50 mL, CAL:1 x 1 mL
R1: 8 x 165 mL, R2: 8 x 55 mL, CAL:1 x 1 mL
R1: 8 x 180 mL, R2: 8 x 60 mL, CAL:1 x 1 mL
R1: 8 x 195 mL, R2: 8 x 65 mL, CAL:1 x 1 mL
R1: 8 x 21 mL, R2: 8 x 7 mL, CAL: 1 x 1 mL
R1: 8 x 210 mL, R2: 8 x 70 mL, CAL:1 x 1 mL
R1: 8 x 225 mL, R2: 8 x 75 mL, CAL:1 x 1 mL
R1: 8 x 240 mL, R2: 8 x 80 mL, CAL:1 x 1 mL
R1: 8 x 255 mL, R2: 8 x 85 mL, CAL:1 x 1 mL
R1: 8 x 270 mL, R2: 8 x 90 mL, CAL:1 x 1 mL
R1: 8 x 28 mL, R2: 8 x 10 mL, CAL:1 x 1 mL
R1: 8 x 30 mL, R2: 8 x 10 mL, CAL: 1 x 1 mL
R1: 8 x 300 mL, R2: 8 x 100 mL, CAL:1 x 1 mL
R1: 8 x 41 mL, R2: 8 x 15 mL, CAL:1 x 1 mL
R1: 8 x 42 mL, R2: 8 x 14 mL, CAL: 1 x 1 mL
R1: 8 x 60 mL, R2: 8 x 20 mL, CAL: 1 x 1 mL
R1: 8 x 75 mL, R2: 8 x 25 mL, CAL: 1 x 1 mL
R1: 8 x 90 mL, R2: 8 x 30 mL, CAL: 1 x 1 mL
R1: 9 x 105 mL, R2: 9 x 35 mL, CAL:1 x 1 mL
R1: 9 x 120 mL, R2: 9 x 40 mL, CAL:1 x 1 mL
R1: 9 x 135 mL, R2: 9 x 45 mL, CAL:1 x 1 mL
R1: 9 x 15 mL, R2: 9 x 5 mL, CAL: 1 x 1 mL
R1: 9 x 150 mL, R2: 9 x 50 mL, CAL:1 x 1 mL
R1: 9 x 165 mL, R2: 9 x 55 mL, CAL:1 x 1 mL
R1: 9 x 180 mL, R2: 9 x 60 mL, CAL:1 x 1 mL
R1: 9 x 195 mL, R2: 9 x 65 mL, CAL:1 x 1 mL
R1: 9 x 21 mL, R2: 9 x 7 mL, CAL: 1 x 1 mL
R1: 9 x 210 mL, R2: 9 x 70 mL, CAL:1 x 1 mL
R1: 9 x 225 mL, R2: 9 x 75 mL, CAL:1 x 1 mL
R1: 9 x 240 mL, R2: 9 x 80 mL, CAL:1 x 1 mL
R1: 9 x 255 mL, R2: 9 x 85 mL, CAL:1 x 1 mL
R1: 9 x 270 mL, R2: 9 x 90 mL, CAL:1 x 1 mL
R1: 9 x 28 mL, R2: 9 x 10 mL, CAL:1 x 1 mL
R1: 9 x 30 mL, R2: 9 x 10 mL, CAL: 1 x 1 mL
R1: 9 x 300 mL, R2: 9 x 100 mL, CAL:1 x 1 mL
R1: 9 x 41 mL, R2: 9 x 15 mL, CAL:1 x 1 mL
R1: 9 x 42 mL, R2: 9 x 14 mL, CAL: 1 x 1 mL
R1: 9 x 60 mL, R2: 9 x 20 mL, CAL: 1 x 1 mL
R1: 9 x 75 mL, R2: 9 x 25 mL, CAL: 1 x 1 mL
R1: 9 x 90 mL, R2: 9 x 30 mL, CAL: 1 x 1 mL

Instruções de Uso e Arquivos(1)

Código	Tipo	Arquivo	Expedição	Expediente
T14769420	INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO	Instrucao de uso_HDL SD_Ref 156.pdf	30/07/2021, 16:50	2975313217

Instrucao de uso_HDL SD_Ref 156.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1476942030/07/2021, 16:50Exp. 2975313217

A atualização destes documentos é executada pela empresa responsável pela regularização do produto.

Documentos Técnicos(1)

Petição / Protocolo	Data	Assunto	Situação
0510519186	20/08/2018	IVD – Alteração de cadastro – Aprovação requerida – Indicação de uso ou uso pretendido, instruções de uso (exceto interferentes e limitações), composição de produtos ou modelo de instrumentos, inclusão de produto no cadastro de família, alteração de informações de amostras biológicas, desempenho analítico (exceto interferentes e limitações), de estabilidade, conservação e prazo de validade e processo de fabricação	Publicado deferimento

051051918620/08/2018

IVD – Alteração de cadastro – Aprovação requerida – Indicação de uso ou uso pretendido, instruções de uso (exceto interferentes e limitações), composição de produtos ou modelo de instrumentos, inclusão de produto no cadastro de família, alteração de informações de amostras biológicas, desempenho analítico (exceto interferentes e limitações), de estabilidade, conservação e prazo de validade e processo de fabricação

Publicado deferimento

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