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510(k) Data Aggregation
K Number
K983107Device Name
VFE
Manufacturer
RAMCO LABORATORIES, INC.
Date Cleared
1998-10-22
(48 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
RAMCO LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VFE assay is an in vitro enzyme immunoassay for quantifying the concentration of von Willebrand Factor Antigen in human plasma to aid in differentiating patients with von Willebrand disease from those with Classical Hemophilia A.
Device Description
VFE is an enzyme immunoassay, in microplate format, intended for the in vitro quantification of von Willebrand Factor antigen in serum or plasma as an aid to differentiate patients with von Willebrand disease from those with classical Hemophilia A. This assay represents an updated technical format, with performance improvements, when compared to the predicate device.
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K Number
K981208Device Name
TFR
Manufacturer
RAMCO LABORATORIES, INC.
Date Cleared
1998-10-21
(202 days)
Product Code
JNM
Regulation Number
866.5880Why did this record match?
Applicant Name (Manufacturer) :
RAMCO LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TFR assay is an in vitro enzyme immunoassay for quantifying the concentration of transferrin receptor in human serum or plasma to aid in the diagnosis of iron deficiency anemia, particularly in the presence of other disease states.
Device Description
The TFR assay is an in vitro enzyme immunoassay based upon the double antibody sandwich method. Plasma or serum samples are diluted in buffer and pipetted into microwells pre-coated with polyclonal antibody to transferrin receptor. Horseradish peroxidase conjugated antibody specific for serum transferrin receptor (STR) is added to the wells and incubated. During this incubation, the STR binds to the polyclonal antibodies adsorbed to the wells and the HRP-conjugated second antibodies bind to the captured STR. Any unbound STR and excess HRP-conjugate are washed from the wells. Enzyme substrate is added to the wells and allowed to incubate, a stop solution is then added to stop the reaction and the intensity of the yellow product is measured in a microplate reader. The optical density of the resulting solution is directly proportional to the concentration of the STR in the standard samples. A standard curve is generated from the STR standards provided in the assay and the concentration of STR in the unknown sample is determined by comparing the unknown's optical density reading with the standard curve graph.
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