AccessGUDID - DEVICE: ANDiS Viral RNA Auto Extraction & Purification Kit (06973685471004)

GUDID

Device Identifier (DI) Information

Brand Name: ANDiS Viral RNA Auto Extraction & Purification Kit
Version or Model: 64 Tests/Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3103010046
Company Name: 3D Biomedicine Science & Technology Co., Limited

Primary DI Number: 06973685471004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 561011079 *Terms of Use

Device Description: The ANDiS Viral RNA Auto Exttaction & Purification Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. The ANDiS Viral RNA Auto Extraction & Purification Kit is intennded for in vitro diagnostic use.

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):	No
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?
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56068e3d-e8ae-4d60-8226-e5138af433df
Public Version Date: January 20, 2021
Public Version Number: 1
DI Record Publish Date: January 12, 2021