9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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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
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
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·March 17, 2021
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 Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·December 14, 2016
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 Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 30, 2020
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 2, 2020
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 Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 2, 2020
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 Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 30, 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 Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·September 30, 2020