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Aortic Pericardial Bioprosthetic Heart Valve
ST. JUDE MEDICAL, INC.
TF-27A
In Commercial Distribution
- 05414734052054 ()
- Outer Diameter: 27 Millimeter
TF-27A
- Aortic open-surgery heart valve bioprosthesis
Aortic Pericardial Bioprosthetic Heart Valve
ST. JUDE MEDICAL, INC.
TF-25A
In Commercial Distribution
- 05414734052047 ()
- Outer Diameter: 25 Millimeter
TF-25A
- Aortic open-surgery heart valve bioprosthesis
Aortic Pericardial Bioprosthetic Heart Valve
ST. JUDE MEDICAL, INC.
TF-21A
In Commercial Distribution
- 05414734052023 ()
- Outer Diameter: 21 Millimeter
TF-21A
- Aortic open-surgery heart valve bioprosthesis
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution
- 20705031050737 ()
- 10705031050730 ()
TC003
- Circulating-fluid endometrial-ablation catheter
Uterine Balloon Therapy System with Fluid Circulation
Ethicon Inc.
TC013
Not in Commercial Distribution
- H206TC0131 ()
- 20705031050744 ()
TC013
- Circulating-fluid endometrial-ablation catheter
Indications for FH:
The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KP-05
In Commercial Distribution
- 14537693900636 ()
- 04537693900639 ()
- Apheresis system filter, whole blood
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
37200
In Commercial Distribution
- H628372001 ()
37200
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
36 test
In Commercial Distribution
- 08887581000016 ()
07110888036
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
18 test
In Commercial Distribution
- 08887581000009 ()
0711088018
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
C22845
In Commercial Distribution
- 15099590701673 ()
C22845
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay