BEUDAMED
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    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular·January 9, 2013

    Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular·July 25, 2012

    ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·October 18, 2017

    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·April 3, 2013

    APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·October 2, 2019

    Clinical Chemistry Phenobarbital, list number 1E08

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·April 24, 2013

    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

    FDA Enforcement
    Class II ·Completed·Abbott Laboratories, Inc·November 29, 2017

    Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·October 23, 2013

    Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·November 5, 2014

    ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·November 4, 2015

    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

    FDA Enforcement
    Class II ·Completed·Abbott Laboratories, Inc·November 29, 2017

    ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·March 14, 2018

    CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc.·August 1, 2018

    ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·March 14, 2018

    ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15 cuvette segments) per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·March 14, 2018

    ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·March 13, 2019

    Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·April 17, 2019

    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·May 15, 2019

    Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·July 31, 2019

    Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·April 17, 2019