FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, specific, analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700571105368PackageGS15In Commercial Distribution
05700571112526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700571105368057005711053685700571105368
05700571112526057005711125265700571112526

GMDN Terms#

Term, Definition table
TermDefinition
Fragile X syndrome IVD, probeA 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
TypeValueUnit
Total Volume100Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-805-566-6655dako.usregulatory@agilent.com

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 DIBrandModelCatalogPublished
05700571112465User-Fillable Reagent Bottle 5mL Capacity (Link)SK2002020-09-17
05700571112472User-Fillable Reagent Bottle 12mL Capacity (Link)SK2012020-09-17
05700571112489User-Fillable Reagent Bottle 25mL Capacity (Link)SK2022020-09-17
05700571112496User-Fillable Reagent Bottle 50mL Capacity (Link)SK2032020-09-17

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