AccessGUDID - DEVICE: Fragile X Fluorescein-Labelled Probe (05700571112526)

GUDID

Device Identifier (DI) Information

Brand Name: Fragile X Fluorescein-Labelled Probe
Version or Model: Y1442
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES, INC.

Primary DI Number: 05700571112526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084963177 *Terms of Use

Device Description: Fragile X Fluorescein-Labelled Probe

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59482	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, specific, analyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Protect from light
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 100 Microliter

Device Record Status

Public Device Record Key: 9c4c9c55-5f85-4615-9329-c996b6e2007b
Public Version Date: December 07, 2020
Public Version Number: 2
DI Record Publish Date: September 17, 2020