ab1e797044a38f395a061ec7a7f19acf
Cepheid's Xpert BCR-ABL Ultra
CEPHEID·III·Ecuador ARCSA·Registered July 27, 2016
Device classification
- Risk class
- III
- Product type
- In Vitro Diagnostic
- Brand name
- XPERT®
- Commercial name
- IVD Reagents/Kits, Molecular Assay, Chromosomal Abnormality, Translocation
- Sterilization method
- . METHODOLOGY: MOLECULAR BIOLOGY
Registration information
- Analysis ID
- ab1e797044a38f395a061ec7a7f19acf
- Registration date
- July 27, 2016
- Expiration date
- July 27, 2026
- Creation date
- July 23, 2021
Manufacturer
- Name
- CEPHEID
- Country
- UNITED STATES
- Address
- 904, CARIBBEAN DRIVE - SUNNYVALE, CA 94089 - USA
Product owner
- Name
- CEPHEID
- Country
- UNITED STATES
Authorized representative
- Address
- TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
- Phone
- 2610680
Product use
QUALITATIVE TEST FOR HIGHER PRECISION BCR-ABL ULTRA
About this record
Access comprehensive regulatory information for Cepheid's Xpert BCR-ABL Ultra in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID ab1e797044a38f395a061ec7a7f19acf and manufactured by CEPHEID. The device was registered on July 27, 2016.
This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.