Pure Global

Syphicheck® - WB Device Rapid Test for Syphilis Serum/Plasma/Whole Blood Modified TPHA - FDA Registration IVDR-00797

Access comprehensive regulatory information for Syphicheck® - WB Device Rapid Test for Syphilis Serum/Plasma/Whole Blood Modified TPHA in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00797 and manufactured by Tulip Diagnostics Private Limited - Gitanjali, Tulip Block, Dr. Antonio Do Rego Bagh, Alto Santacruz, Bambolin Complex, P.O. Goa - 403 202, India Mfd by: Zephyr Biomedicals - A Division of Tulip Diagnostic (P) Ltd. - Plot No. M-46/47, Phase III B, Verna Industrial Estate, Verna, Goa - 403 722, India in India.. The device was registered on May 21, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Biosite Medical Instruments), 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.

Free Database
Powered by Pure Global AI
FDA Official Data
India.
IVDR-00797
Syphicheck® - WB Device Rapid Test for Syphilis Serum/Plasma/Whole Blood Modified TPHA
Registered medical device in Philippines
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Product Name
Syphicheck® - WB Device Rapid Test for Syphilis Serum/Plasma/Whole Blood Modified TPHA
Registration Number
IVDR-00797
Importer & Distribution
Importer/Distributor
Biosite Medical Instruments
Registration Dates
Issuance Date
May 21, 2025
Expiry Date
February 08, 2030