Philippines FDA registration IVDR-00941

Xpert® HIV-1 Viral Load XC

Name: Xpert® HIV-1 Viral Load XC — Philippines FDA registration IVDR-00941
Creator: Cepheid AB - Rontgenvagen 5, SE-171 54, Solna, Sweden
Keywords: Xpert® HIV-1 Viral Load XC, IVDR-00941, Cepheid AB - Rontgenvagen 5, SE-171 54, Solna, Sweden, Macare Medicals, Inc., Sweden, Philippines FDA registration

PhilippinesCepheid AB - Rontgenvagen 5, SE-171 54, Solna, SwedenSwedenIssued March 20, 2025 – March 20, 2026

VerifiedFDA Philippines · official registry

Device information

Product Name: Xpert® HIV-1 Viral Load XC
Registration Number: IVDR-00941

Manufacturer details

Manufacturer: Cepheid AB - Rontgenvagen 5, SE-171 54, Solna, Sweden
Country of Origin: Sweden

Importer & distribution

Importer/Distributor: Macare Medicals, Inc.

Registration dates

Issuance Date: March 20, 2025
Expiry Date: March 20, 2026

About this record

Access comprehensive regulatory information for Xpert® HIV-1 Viral Load XC in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00941 and manufactured by Cepheid AB - Rontgenvagen 5, SE-171 54, Solna, Sweden in Sweden. The device was registered on March 20, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Macare Medicals, Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.