4 results
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15ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·May 29, 2013
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·August 3, 2016