28 results
·
41ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. 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 Enforcement
Class II
·Terminated·Princeton Biomeditech Corp·September 12, 2012
OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·April 27, 2016
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. 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
OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code MZO·January 15, 2016
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code LAF·February 5, 2021
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. 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
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
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code JXM·July 13, 2020
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code GEH·July 15, 2020
Cannabinoids Intercept Micro Plate EIA 100 plate kit
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code LDJ·September 8, 2008
Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code LDJ·September 8, 2008
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code DIS·November 10, 2016
Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code LDJ·September 8, 2008
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
FDA Recall
Terminated
·OraSure Technologies, Inc.·July 20, 2016
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code JXM·July 13, 2020
Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code LDJ·September 8, 2008
Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code GEH·July 15, 2020
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code GEH·July 15, 2020
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code DIO·December 20, 2017
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·April 25, 2018