BEUDAMED
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    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code NEO·August 10, 2012

    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code JIT·August 10, 2012

    IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code NEO·August 10, 2012

    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code JMM·August 10, 2012

    Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries, Inc.·Product code LRO·March 18, 2005

    2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 40054; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number CDS980652A, Thoracic Anesthesia Pack; 2) Item Number CDS980955, Affinity Shoulder Arthroscopy; 3) Item Number CDS980956, Affinity Total Hip CDS; 4) Item Number CDS980957, Affinity Total Knee CDS; 5) Item Number DYNJAA4758B, Circuit Adult Anesthesia; 6) Item Number DYNJAA4777, Adult 40in Anesth w/HME-LF; 7) Item Number DYNJAA9796, Anes Circuit 90in EXP Adult-LF; 8) Item Number DYNJAA9847A, Adult Circuit; 9) Item Number DYNJAA9904, Circuit Adult Anesthesia; 10) Item Number DYNJAA9904A, Circuit Adult Anesthesia; 11) Item Number DYNJAA9906, Circuit Adult Anesthesia; 12) Item Number DYNJAA9933, Anesthesia Super Circuit; 13) Item Number DYNJAAF6318A, Adult Anesthesia Circuit; 14) Item Number DYNJAP4726, Pedi Circuit 40in; 15) Item Number DYNJAP4737A, Circuit Pediatric Anesthesia; 16) Item Number DYNJAP4737B, Circuit Pediatric Anesthesia; 17) Item Number DYNJAP4737C, Circuit Pediatric Anesthesia; 18) Item Number DYNJAP4744, Pediatric Anesthesia Circuit; 19) Item Number DYNJAP6138, Circuit Pediatric Anesthesia; 20) Item Number DYNJAP7258, Circuit Pediatric Anesthesia; 21) Item Number DYNJAP7259, Peds Anesthesia Circuit; 22) Item Number DYNJAPF6007, Circuit Ped Uni 60in-LF; 23) Item Number DYNJAPF6012, Circuit Pediatric Anesthesia. Medline Industries Inc., Mundelein, IL 60060.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code BTC·December 7, 2007