BEUDAMED
    18 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·October 21, 2015

    IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·April 24, 2013

    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

    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·August 8, 2018

    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ¿ as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ¿ as an aid in the assessment of severity of congestive heart failure ¿ for the risk stratification of patients with acute coronary syndromes ¿ for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·July 2, 2014

    Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·October 30, 2013

    Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·February 6, 2013

    Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·February 6, 2013

    Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·December 4, 2013

    Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·September 21, 2016

    Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego Inc. DBA Immunalysis Corporation·June 20, 2018