AmplideX Fragile X Dx & Carrier Screen Kit

Basic Information

• Brand Name: AmplideX Fragile X Dx & Carrier Screen Kit
• Primary DI: 00863840000254
• Version / Model: 49591
• Catalog Number: 49591
• Company Name: ASURAGEN, INC.
• Labeler DUNS: 622988330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-07
• Public Version: 1
• Public Version Date: 2020-04-15
• Public Version Status: New
• Public Device Record Key: 04a6fb18-5ac0-4b00-bdd8-770addffa1dd

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OYV	Inherited Nucleotide Repeat Disorder Dna Test	Immunology	866.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59480	Fragile X syndrome IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder Fragile X syndrome, using a nucleic acid technique (NAT). 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863840000254	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN190023	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -15 Degrees Celsius