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# Ortho Sera Extended Antigen Phenotyping Cleared
- URL: https://www.fdaweb.com/ortho-sera-extended-antigen-phenotyping-cleared/
- Published: 2019-10-18T12:00:00.000Z
- Updated: 2026-09-15T01:57:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145284

FDA has cleared an Ortho Clinical Diagnostics 510(k) for the [**ORTHO Sera**](https://c212.net/c/link/?t=0&l=en&o=2615422-1&h=4123155438&u=https%3A%2F%2Fwww.orthoclinicaldiagnostics.com%2Fen-us%2Fhome%2Fproducts%2FORTHO%2520Sera%2520NOW%2520available&a=ORTHO%E2%84%A2+Sera&ref=fdaweb.com), a series of extended antigen phenotyping for use on the Ortho Vision Analyzer. The device’s extended phenotype testing covers more than 99% of the most commonly tested blood group antigens to support for patients with unexpected antibodies, the company says. The phenotyping is fully automated and intended to minimize the potential for human error, it says.