AccessGUDID - DEVICE: AmplideX Fragile X Dx & Carrier Screen Kit (00863840000254)

GUDID

Device Identifier (DI) Information

Brand Name: AmplideX Fragile X Dx & Carrier Screen Kit
Version or Model: 49591
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 49591
Company Name: ASURAGEN, INC.

Primary DI Number: 00863840000254
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622988330 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYV	Inherited Nucleotide Repeat Disorder Dna Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190023	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -30 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 04a6fb18-5ac0-4b00-bdd8-770addffa1dd
Public Version Date: April 15, 2020
Public Version Number: 1
DI Record Publish Date: April 07, 2020