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Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995517
In Commercial Distribution
- 00630414598444 ()
- 00630414190884 ()
10995517
- Total prostate specific antigen (tPSA) IVD, calibrator
Indications for FH:
The Apheresis Machine KANEKA MA-03 is 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 Apheresis Machine KANEKA MA-03 is 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
KANEKA MA-03
In Commercial Distribution
- 04987671040374 ()
- Apheresis system
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 Sample Diluent is intended for use with the Access Hybritech PSA assay to dilute patient samples containing total prostate specific antigen (PSA) concentrations greater than the S5 calibrator.
Beckman Coulter, Inc.
37206
In Commercial Distribution
- H628372061 ()
37206
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybritech PSA assay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
37205
In Commercial Distribution
- H628372051 ()
37205
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
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
RECELL GO mini Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0105
In Commercial Distribution
- 00851707004361 ()
- Autologous skin cell grafting kit
RECELL GO Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0103
In Commercial Distribution
- 00851707004286 ()
- Autologous skin cell grafting kit
RECELL GO Autologous Cell Harvesting Device (Processing Device)
AVITA MEDICAL AMERICAS, LLC
AVRL0104
In Commercial Distribution
- 00851707004279 ()
- Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution
- 00851707004200 ()
AVRL0101
- Autologous skin cell grafting kit