Home GUDID 05700571105368 Fragile X Fluorescein-Labelled Probe
Primary DI 05700571105368
Brand Fragile X Fluorescein-Labelled Probe
Company Dako North America, Inc.
Model Y1442
Device description Fragile X Fluorescein-Labelled Probe
Published 2020-09-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name MVU Reagents, specific, analyte
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MVU Reagents, Specific, Analyte Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05700571105368 Package GS1 5 In Commercial Distribution 05700571112526 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05700571105368 05700571105368 5700571105368 05700571112526 05700571112526 5700571112526
GMDN Terms# Term, Definition table Term Definition Fragile X syndrome 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 the inborn genetic disorder Fragile X syndrome. The disorder results in mild to moderate mental retardation and is associated with trinucleotide repeat expansion or deletion of the CCG triplet in the FMR1 and/or FMR2 genes located on the X chromosome.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 100 Microliter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Protect from light Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 099999732 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05700571112465 User-Fillable Reagent Bottle 5mL Capacity (Link) SK200 2020-09-17 05700571112472 User-Fillable Reagent Bottle 12mL Capacity (Link) SK201 2020-09-17 05700571112489 User-Fillable Reagent Bottle 25mL Capacity (Link) SK202 2020-09-17 05700571112496 User-Fillable Reagent Bottle 50mL Capacity (Link) SK203 2020-09-17
Other Devices Sharing Product Codes# 
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