5 results
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31ms
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Sources: EU EUDAMED, US FDA
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Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc·April 10, 2013
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc·April 10, 2013
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc·September 26, 2018
PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc·September 26, 2018
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
FDA Enforcement
Class III
·Ongoing·POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC·November 26, 2025