Home GUDID 00884999008366 Vysis
Primary DI 00884999008366
Brand Vysis
Company ABBOTT MOLECULAR INC.
Model 04N37-020
Catalog number 04N37-020
Device description Vysis EGR1 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 OWK Early growth response 1 (egr) fish probe kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OWK Early Growth Response 1 (Egr) Fish Probe Kit Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884999008366 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 00884999008366 00884999008366 884999008366 0884999008366
GMDN Terms# Term, Definition table Term Definition Acute myeloid leukaemia (AML) 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 acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17).
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 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# 
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