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The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]proPSA antigen, an isoform of free PSA, in human serum using the Access Immunoassay Systems. Access Hybritech p2PSA is intended to be used in combination with Access Hybritech (total) PSA and Access Hybritech free PSA to calculate the Beckman Coulter Prostate Health Index (phi), an In Vitro Diagnostic Multivariate Index
Assay (IVDMIA). Beckman Coulter phi as calculated using the Access Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
B03704
In Commercial Distribution
- H628B037041 ()
B03704
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
37210
In Commercial Distribution
- H628372101 ()
37210
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
C22846
In Commercial Distribution
- 15099590701680 ()
C22846
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
ET CONTROL OPTION
DATEX-OHMEDA INC
AISYS CS2
In Commercial Distribution
- 00195278579157 ()
- Anaesthesia workstation, general-purpose
DQA phantom (tissue mimic) gel for calibration prior neuro MR-guided FUS treatment.
a part of 1.5T neuro kit (SET000937) and 3T neuro kit (SET000936)
INSIGHTEC LTD
NEURO DQA PHANTOM GEL
In Commercial Distribution
- 07290015461207 ()
SET000932
- Therapeutic oncological/gynaecological ultrasound system
Millennia Acupuncture Needle is well known for its superior quality, affordability and performance. It is one of the best acupuncture needles in the world.
UPC MEDICAL SUPPLIES, INC.
A-1M 0.35 X 40
In Commercial Distribution
- 00831592003342 ()
- 00008315920000 ()
- Length: 40 Millimeter
- Outer Diameter: 0.35 Millimeter
- Acupuncture needle, single-use
Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951
AVM-951
- Fallopian tube clip/band
Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951
Not in Commercial Distribution
- 25055515602187 ()
- 15055515602180 ()
AVM-951
- Fallopian tube clip/band
3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image.
Hologic, Inc.
3DQUORUM SOFTWARE
In Commercial Distribution
- 15420045512313 ()
SW-05673
- Stationary mammographic x-ray system, digital
The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Inspire Medical Systems, Inc.
900-014-005
In Commercial Distribution
- 10810098650301 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing