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510(k) Data Aggregation
K Number
K994356Device Name
IMMUNOCYT
Manufacturer
Date Cleared
2000-02-23
(62 days)
Product Code
Regulation Number
864.1860Why did this record match?
Product Code :
NBK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ImmunoCyt is a qualitative direct immunocytofluorescence assay intended for use in conjunction with cytology to increase the overall sensitivity for the detection of tumor cells exfoliated in the urine of patients previously diagnosed with bladder cancer. ImmunoCyt is indicated for use as an aid in the management of bladder cancer in conjunction with urinary cytology and cystoscopy.
Device Description
ImmunoCyt is an in vitro diagnostic device that contains a solution of three monoclonal antibodies. Two antibodies are reactive to epitopes selectively detected on a mucin found in bladder cancer cells, and one antibody reacts with a bladder cancer-associated glycosylated form of the carcinoembryonic antigen. The antibodies are coupled with fluorescent markers. This solution is used to detect tumor cells exfoliated in the urine of bladder cancer patients. ImmunoCyt also contains a sample fixative and a blocking solution, as well as positive and negative control cells.
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