Home GUDID 00884999007772 Vysis
Primary DI 00884999007772
Brand Vysis
Company ABBOTT MOLECULAR INC.
Model 04N02-020
Catalog number 04N02-020
Device description Vysis CLL FISH Probe Kit
Published 2016-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name OVQ Chronic lymphocytic leukemia fish probe kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVQ Chronic Lymphocytic Leukemia Fish Probe Kit Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884999007772 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00884999007772 00884999007772 884999007772 0884999007772
GMDN Terms# Term, Definition table Term Definition Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe A defined piece of single-stranded nucleic acid which is used to identify specific complementary sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict chronic lymphocytic leukaemia (CLL) based on changes at the gene or chromosomal level, which may involve genetic markers on chromosomes 11, 12, 13 and 17.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 The kit must be protected from light when not in use. The NP-40 and 20X SSC Salt may be stored separately at room temperature. Storage Environment Temperature -30 Degrees Celsius -10 Degrees Celsius
Regulatory Flags# DUNS number 878263359 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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