ANVISA registration

Família ichroma CA19-9

Registration 10350840440. ANTÍGENO CA 19-9

Registration details

Registration number10350840440
Application number25351501617202393
Technical nameANTÍGENO CA 19-9
Risk classIII
Published on20/11/2023
ValidityValid until 20/11/2033

Registration holder

Legal nameBIOSYS LTDA
CNPJ02.220.795/0001-79

Manufacturer

  • BODITECH MED INC. CORÉIA DO SUL

Other registrations held by BIOSYS LTDAview all

ALFA-AMYLASE CC FS* (ALFA-AMILASE CC FS*)

10350840001

BILIRUBIN AUTO DIRECT FS* (BILIRRUBINA AUTODIRETA FS*)

10350840002

CALCIUM FS* (CALCIO FS*)

10350840003

BILIRRUBIN AUTO TOTAL FS*(BILIRRUBINA AUTO TOTAL FS*)

10350840007

GPT (ALAT) FS* IFCC (MOD)

10350840008

CK-NAC FS*DGKC / IFCC

10350840009

Source: ANVISA

Source: ANVISA open data, medical device file, updated daily. The public database provides registration validity, rather than registration status: this registration may have been cancelled before its expiry date without this being shown here. Before making purchasing, import or marketing decisions, check the ANVISA search portal.

Next step

Medical device registration with ANVISA

HSC manages the process from risk classification to liaising with the regulator, in Brazil and more than 40 other countries.

Speak to a specialist