GenetiSure Dx Postnatal Assay

Basic Information

• Brand Name: GenetiSure Dx Postnatal Assay
• Primary DI: 05700571108697
• Version / Model: K1201A
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-07
• Public Version: 5
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 5d2d9798-ca0c-4e30-9218-3b463db27de0

Device Description

GenetiSure Dx Postnatal Assay

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFX	System, microarray-based, genome-wide, postnatal chromosomal abnormality detection	Immunology	866.5920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62428	Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative detection of genome copy number variations (CNV) associated with intellectual disability, developmental delay, congenital anomalies, and/or dysmorphic features, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700571108697	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K163367	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			24 tests

Storage Conditions

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