Babio

GUDID 06975025173852

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.

Jinan Babio Biotechnology Co., Ltd.

Cytology specimen container IVD, transport buffer

• Primary Device ID: 06975025173852
• NIH Device Record Key: dcedf697-0c70-437c-91c1-b29d655ffe6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babio
• Version Model Number: VTM
• Company DUNS: 527015617
• Company Name: Jinan Babio Biotechnology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975025173852 [Primary]

FDA Product Code

• QMC: Transport Medium, Notified Per The Vtm Guidance

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-22
• Device Publish Date: 2023-02-14

On-Brand Devices [Babio]

• 06975025173814: Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of cl
• 06975025173852: Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of cl