PROCALCITONIN PCT - CLASS II - ANVISA Registration 80105220164
Access comprehensive regulatory information for PROCALCITONIN PCT - CLASS II in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80105220164 and manufactured by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA. The registration is held by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including BODITECH MED INC., DIASORIN ITALIA S.P.A., and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
80105220164
25351880313202381
04299232000143
Company Information
Dates and Status
Jan 15, 2024
VIGENTE
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
FASTLINE MIOGLOBINA + CKMB + TROPONINA I
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220200
Jun 17, 2024
HUMAN BRAIN NATRIURETIC PEPTIDE (BNP)
FASTLINE NT-proBNP
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220194
May 13, 2024
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS III
FASTLINE H-FABP + MIOGLOBINA + CKMB + TROPONINA I
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220195
Jun 17, 2024
TROPONIN
FASTLINE TROPONINA I
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220186
Apr 15, 2024
HUMAN BRAIN NATRIURETIC PEPTIDE (BNP)
FASTLINE FIA NT-proBNP
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220242
Dec 23, 2024
BODITECH MED INC.• South Korea
DIASORIN ITALIA S.P.A.• Italy
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.• China
SIEMENS HEALTHCARE DIAGNOSTICS INC• United States of America
PROCALCITONINA PCT - CLASSE II
Kit de Teste Rápido Procalcitonina (PCT) (Teste Imunocromatográfico por Fluorescência)
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
82444370086
Jan 22, 2024
PROCALCITONINA PCT - CLASSE II
FamÃlia AutoLumo PCT MicropartÃculas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513101
Oct 09, 2023
PROCALCITONINA PCT - CLASSE II
FamÃlia Dimension Procalcitonina (PCT)
SIEMENS HEALTHCARE DIAGNOSTICS INC
10345162465
May 02, 2023
PROCALCITONINA PCT - CLASSE II
Procalcitonina (Imunoensaio de Eletroquimioluminescência)
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80102512990
Apr 17, 2023
PROCALCITONINA PCT - CLASSE II
FIA PCT
GOLD ANALISA DIAGNOSTICA LTDA
80022230244
May 19, 2022