AccessGUDID - DEVICE: GenetiSure Dx Postnatal Assay (05700571108697)

GUDID

Device Identifier (DI) Information

Brand Name: GenetiSure Dx Postnatal Assay
Version or Model: K1201A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES, INC.

Primary DI Number: 05700571108697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084963177 *Terms of Use

Device Description: GenetiSure Dx Postnatal Assay

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:	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?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFX	System, microarray-based, genome-wide, postnatal chromosomal abnormality detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163367	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 24 tests

Device Record Status

Public Device Record Key: 5d2d9798-ca0c-4e30-9218-3b463db27de0
Public Version Date: February 01, 2024
Public Version Number: 5
DI Record Publish Date: November 07, 2017