AccessGUDID - DEVICE: STARMag 96x4 Universal Cartridge Kit (08809240000007)

GUDID

Device Identifier (DI) Information

Brand Name: STARMag 96x4 Universal Cartridge Kit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 744300.4.UC384
Company Name: SEEGENE, INC.

Primary DI Number: 08809240000007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688370667 *Terms of Use

Device Description: for isolation of nucleic acid from tissue, cells, bacteria, serum, plasma, nasopharyngeal swab, nasopharyngeal aspirates, bronchoalveolar lavage (BAL), urine, stool, sputum, whole blood, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), cerebrospinal fluid (CSF), semen and saliva specimen using automated liquid handling instrument

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):	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?
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
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db9679cf-3236-4ee1-b9b4-8da619406e76
Public Version Date: December 13, 2022
Public Version Number: 1
DI Record Publish Date: December 05, 2022