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    JTC Diagnosemittel GmbH

    Manufacturer
    🇩🇪 Germany

    Tenacath

    FDA UDI
    COOK INCORPORATED·00827002169098·Tenacath Tip Extender

    Tenacath

    FDA UDI
    COOK INCORPORATED·00827002166332·Tenacath HSG

    UNKNOWN J & J TC III KNEE

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code HRY·May 13, 2005

    THERMOCOOL SF CARTO 3,F-J,TC

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·November 20, 2019

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·May 16, 2013

    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011

    JTC Diagnosemittel GmbH

    Importer
    🇩🇪 Germany

    JTC Diagnosemittel GmbH

    Authorized representative
    🇩🇪 Germany

    BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTC·July 26, 2019

    BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTC·July 26, 2019

    Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400. Hamilton Company, Reno, NV 89520 (Accessory on the Microlab STAR series instruments.)

    FDA Recall
    Terminated ·Hamilton Co·Product code JTC·June 25, 2007

    Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU. Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036

    FDA Recall
    Terminated ·Hamilton Co·Product code JTC·December 13, 2005

    300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case, manufactured by Hamilton Company, Reno, NV. The products are a disposable product that are used with the Microlab STAR series instruments, which are microtiter diluting and dispensing devices.

    FDA Recall
    Terminated ·Hamilton Co·Product code JTC·December 1, 2008

    300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company, Reno, NV. Product is a disposable product used with Microlab STAR series Instruments, which are microtiter diluting and dispensing devices.

    FDA Recall
    Terminated ·Hamilton Co·Product code JTC·April 9, 2009

    Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code JTC·May 20, 2004

    BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTC·March 22, 2023

    Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), Manufactured by Hamilton Company, Reno, Nevada

    FDA Recall
    Terminated ·Hamilton Co·Product code -JTC·January 30, 2007

    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.

    FDA Recall
    Terminated ·Copan Italia Via Perotti, 10 Brescia Italy·Product code JTC·August 9, 2013

    Device, Microtiter Diluting/Dispensing

    FDA classification
    FDA Class 1 ·Device, Microtiter Diluting/Dispensing