180 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
×
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·December 28, 2016
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012
Optilite IgG4 Kit Product Code: LK009.OPT.A
FDA Enforcement
Class III
·Terminated·The Binding Site Group, Ltd.·February 1, 2017
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD, Inc.·February 4, 2015
Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
FDA Enforcement
Class III
·Terminated·R & D Systems, Inc.·January 9, 2019
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 13, 2025
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
FDA Enforcement
Class III
·Terminated·Pointe Scientific, Inc.·September 23, 2015
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·November 18, 2015
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·December 28, 2016
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
Total Knee Pack, REF CETJ130, medical convenience kits
FDA Enforcement
Class III
·Ongoing·American Contract Systems, Inc.·June 21, 2023
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics Inc·August 31, 2016
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
The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·September 21, 2016
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
FDA Enforcement
Class III
·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·July 11, 2012
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
FDA Enforcement
Class III
·Terminated·ELITech Clinical Systems SAS·October 8, 2014
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.
FDA Enforcement
Class III
·Terminated·Access Scientific LLC·July 22, 2020
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012