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Proper listings and approvals are very important to us!
FDA APPROVAL – USA
Our US-FDA registered products are manufactured in world class GMP factories for laboratory, clinical, and Point of Care (POC) use.
FDA Registration & Establishment Listing for assaya
FDA Registration and Establishment Listing for Apollo BioTech
FDA APPROVAL – TAIWAN
Our Taiwan-FDA registered products are manufactured in world class GMP factories for laboratory, clinical, and Point of Care (POC) use.
FDA Taiwan License
SUCCESSFUL GMP AUDIT
Assaya products are manufactured in Good Manufacturing Practice (GMP) Certified factories, which ensures that our products are consistent and controlled through the highest of quality standards.
FDA Taiwan GMP License
ANVISA BRAZIL
Our ANVISA approved products are manufactured in world class GMP factories for laboratory, clinical, and Point of Care (POC) use.
Proxima by Vyttra Brazil iaX Implementation
DCGI INDIA
Our DCGI registered products are manufactured in world class GMP factories for laboratory, clinical, and Point of Care (POC) use.
Assaya & Intel Collaboration in India
IVDR IVDD EUROPE
Our product notification is under the In Vitro Diagnostics Directive (IVDD). The IVDD applies until the IVDR becomes effective on May 26, 2022. This allows for assaya products to be available for laboratory, clinical, and Point of Care (POC) use in Europe.
Assaya iaX-2101 Used In Robotic Mass Testing in Germany
MEDICAL DEVICE LICENCE TAIWAN
Apollo BioTech Co., Ltd. is licensed by New Taipei City Xizhi District Health Bureau to sell medical devices (License No. 6231047500). Person in charge: Clas Sivertsen. Issued under Article 13 of Taiwan’s Medical Equipment Management regulations.
EUDAMED REGISTRATION
Assaya obtained EUDAMED, which allows for all parts of our IVDD and IVDR to be fully compliant and operational.
TESTING & PROVIDING SUPPORT DURING COVID-19
Assaya provides affordable and equitable human error reducing diagnostics at scale, with real-time reporting. Our mission is to provide the world with reliable, augmented, practical, and inexpensive diagnostics (RAPID) that can be deployed anywhere, anytime, to identify biomarkers and dangerous pathogens in near real-time. We help people everywhere shift from illness to wellness, and prevent the spread of disease, in a sustainable and ethically responsible manner.
160 Robinson Road,
#14-04 Singapore Business
Federation Centre
Singapore 068914
300 Colonial Center Parkway
STE 100N
Roswell, GA
30076, USA
ZhongShan N.Rd
Sec 3 no 40-2F
Zhongshan District
Taipei City, 104
Taiwan
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