34 results
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30ms
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Sources: EU EUDAMED, US FDA
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.
FDA registration
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.·23 products·🇺🇸 United States
Poly stat
FDA UDI
POLYMEDCO, INC.·00855574005377·Qualitative HCG Control
Poly stat
FDA UDI
POLYMEDCO, INC.·00855574005421·Strep A, Immunochromatographic
Poly stat
FDA UDI
POLYMEDCO, INC.·00855574005384·HCG, Immunochromatographic Test
Poly stat
FDA UDI
POLYMEDCO, INC.·00855574005414·H. Pylori, Immunochromatographic
Poly stat
FDA UDI
POLYMEDCO, INC.·00855574005391·Qualitative HCG Control, Urine
PolyTiter
FDA UDI
POLYMEDCO, INC.·00855574005360·Anti Nuclear Antibody, Calibrator, PolyTiter
Poly stat
FDA UDI
POLYMEDCO, INC.·00855574005407·Flu A & B, Immunochromatographic
Poly stat
FDA UDI
POLYMEDCO, INC.·00816917021546·Mono, Immunochromatographic
Poly stat
FDA UDI
POLYMEDCO, INC.·00816917022925·Flu A & B, Immunochromatographic, 25 Test Kit
Poly stat
FDA UDI
POLYMEDCO, INC.·00855574005438·Strep A, Immunochromatographic, Flip
POLYSTAT HCG TEST
FDA Adverse Event
Malfunction
·POLYMEDCO, INC.·Product code JHI·October 14, 2003
SEDIPLAST WESTERGREN ESR SYSTEM
FDA Adverse Event
Malfunction
·POLYMEDCO, INC.·Product code JPH·October 15, 2020
SEDIPLAST
FDA Adverse Event
Malfunction
·POLYMEDCO, INC.·Product code JPH·September 28, 2012
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Recall
Terminated
·Polymedco, Inc·Product code KHE·February 12, 2013
POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.
FDA Recall
Terminated
·Polymedco, Inc·Product code DCK·December 3, 2003
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Recall
Terminated
·Polymedco, Inc·Product code KHE·February 12, 2013
POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum
FDA Recall
Terminated
·Polymedco, Inc·Product code DCK·December 3, 2003
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
FDA Recall
Terminated
·Princeton Biomeditech Corp·Product code GNX·March 9, 2012
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