International product information

The product details shown after you switch describe the versions of Rho authorized outside the United States, including the Rho Score, which is not part of the US version.

US product information

The product details shown after you switch describe the version of Rho authorized in the United States, which reports whether a patient is Rho Positive.

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Regulatory

Singapore's Health Sciences Authority registers Rho

Singapore. Singapore's Health Sciences Authority (HSA) registered Rho (version 3.0.0) on the Singapore Medical Device Register as a Class B medical device, registration MDPR250715C0001, allowing it to be supplied and used clinically in Singapore.

The registrant in Singapore is PE Pharma Pte. Ltd. In September 2025, 16 Bit won CHISEL Healthcare InnoMatch 2025 and was paired with NHG Health to test Rho at Tan Tock Seng Hospital.