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1) OnSite FOB Rapid test (50 ng/ml) 2) OnSite FOB-Hi Rapid test (25 ng/ml) 3) Positivia FOB Rapid Test External Control Kit

Argentina Medical Device Registration · 1) OnSite FOB Rapid test (50 ng/ml) 2) OnSite FOB-Hi Rapid test (25 ng/ml) 3) Positivia FOB Rapid Test External Control Kit · CROMOION Ltd. · Registered June 21, 2023

IVD Modification Group A and B
Device classification
Registration Type
IVD Modification Group A and B
Modificación IVD Grupo A y B
Product Code
908-202
Brand Name
1) OnSite FOB Rapid test (50 ng/ml) 2) OnSite FOB-Hi Rapid test (25 ng/ml) 3) Positivia FOB Rapid Test External Control Kit
Product Name
1) OnSite FOB Rapid test (50 ng/ml) 2) OnSite FOB-Hi Rapid test (25 ng/ml) 3) Positivia FOB Rapid Test External Control Kit
Registration information
Registration Date
June 21, 2023
Database ID
cmhaytp5u06tdekuzefa7s5jw
Authorized representative
Name
CROMOION Ltd.
CROMOION SRL.
Documents
Product information

1) R2010C 2) R2011C 3) C2011

About this record

Access comprehensive regulatory information for 1) OnSite FOB Rapid test (50 ng/ml) 2) OnSite FOB-Hi Rapid test (25 ng/ml) 3) Positivia FOB Rapid Test External Control Kit in the Argentina medical device market through Pure Global AI's free database. This IVD Modification Group A and B medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on June 21, 2023.

This page provides complete registration details including product code (908-202), brand name (1) OnSite FOB Rapid test (50 ng/ml) 2) OnSite FOB-Hi Rapid test (25 ng/ml) 3) Positivia FOB Rapid Test External Control Kit), authorized representative information, registration type, and regulatory compliance data from the official Argentina ANMAT medical device database. Pure Global AI offers free access to Argentina's medical device registry, helping global MedTech companies navigate Argentina regulations efficiently.

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