Vysis CLL FISH Probe Kit - Taiwan Registration a033b0f7e4ac99ff0a521dcc24f964ee
Access comprehensive regulatory information for Vysis CLL FISH Probe Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number a033b0f7e4ac99ff0a521dcc24f964ee and manufactured by ABBOTT MOLECULAR INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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Device Details
Registration Details
a033b0f7e4ac99ff0a521dcc24f964ee
Ministry of Health Medical Device Import No. 030478
DHA05603047801
Product Details
This product can detect gene deletions in probe targets such as TP53, ATM and D13S319 by fluorescence in situ hybridization in blood samples of patients with B-cell chronic lymphocytic leukemia (CLL), as well as the increase in genes in D12Z3 sequence probe targets. For untreated patients, this assay can be used to divide CLL into two groups (13q deletion, trichromosome 12, or normal gene groups corresponding to 11q deletion or 17p deletion) and can be combined with additional biomarker, morphology, and other clinical information to help confirm disease prognosis. This test is recommended to detect defects (17p deletions) in TP53-specific locus probe targets to help determine which patients with CLL can be treated with Venclexta (venetoclax). This product is not intended to observe residual disease. This test can only be used according to prescription, and whether the patient is suitable for treatment with the drug Venclexta needs to be judged by the physician according to the application of the generic drug order.
B Hematology and pathology devices
B1860 Immunopathological histochemical reagents and kits
Imported from abroad
Dates and Status
Jan 09, 2018
Jan 09, 2028