AccessGUDID - DEVICE: Babio (06975025173852)

GUDID

Device Identifier (DI) Information

Brand Name: Babio
Version or Model: VTM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jinan Babio Biotechnology Co., Ltd.

Primary DI Number: 06975025173852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 527015617 *Terms of Use

Device Description: Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. It measures viral particles in the samples using molecular or antigen assays. Not intended for internal 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:	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?
57952	Cytology specimen container IVD, transport buffer	A covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMC	Transport Medium, Notified Per The Vtm Guidance

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: dcedf697-0c70-437c-91c1-b29d655ffe6d
Public Version Date: May 08, 2023
Public Version Number: 2
DI Record Publish Date: February 14, 2023