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Adept (4% icodextrin solution) is a single use, sterile, clear, colorless to pale yellow
fluid for intraperitoneal administration, containing icodextrin at a concentration of 4%
w/v in an electrolyte solution, presented in a flexible polyvinylchloride bag.
Adept is indicated for use intraperitoneally as an adjunct to good surgical technique for
the reduction of post-surgical adhesions in patients undergoing gynecological
laparoscopic adhesiolysis.
BAXTER INTERNATIONAL INC.
0600041
In Commercial Distribution
- 00085412086217 ()
- 50085412086212 ()
- Total Volume: 1500 Milliliter
0600041
- Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6404-01-300
In Commercial Distribution
- 00817491021342 ()
- 00817491023056 ()
- Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6400-01-300
In Commercial Distribution
- 00817491021335 ()
- 00817491021359 ()
N/A
- Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6403-01-300
Not in Commercial Distribution
- 00817491021311 ()
FG-6403-01-300
- Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6402-01-300
In Commercial Distribution
- 00817491021304 ()
- 00817491021342 ()
FG-6402-01-300
- Implantable glucose monitoring system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6401-01-300
In Commercial Distribution
- 00817491021328 ()
- 00817491021298 ()
- 00817491021359 ()
FG-6401-01-300
- Implantable glucose monitoring system
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
The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere NMP22® (ELISA)Test Kit .
Alere Scarborough, Inc.
D2100E
In Commercial Distribution
- 10811877010637 ()
- Nuclear matrix protein 22 IVD, reagent