AccessGUDID - DEVICE: BIOER GenePure 96 Nucleic Acid Purification System (06973843220185)

GUDID

Device Identifier (DI) Information

Brand Name: BIOER GenePure 96 Nucleic Acid Purification System
Version or Model: NPA-96E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hangzhou Bioer Technology Co., Ltd.

Primary DI Number: 06973843220185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545256935 *Terms of Use

Device Description: For the detail information, please refer to the IFU.

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:	No
Prescription Use (Rx):	No
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?
60736	Nucleic acid sample preparation instrument IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.	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: 103c520d-4270-471c-a2c1-c329fd9d9cdf
Public Version Date: January 19, 2023
Public Version Number: 1
DI Record Publish Date: January 11, 2023