BioTeke

GUDID 06974541564526

Bioteke Corporation (Wuxi) Co., Ltd.

General specimen collection kit IVD, clinical

• Primary Device ID: 06974541564526
• NIH Device Record Key: 315ee0e0-6eac-440d-884b-2cbd1761f5b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTeke
• Version Model Number: ST9001-2
• Company DUNS: 560011452
• Company Name: Bioteke Corporation (Wuxi) Co., Ltd.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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	06974541564526 [Primary]
GS1	86974541564522 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211707

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [BioTeke]

• 86974541564065: ST9001-2
• 86974541563044: ST7001-2
• 86974541563020: ST7001-1
• 06974541563024: ST7001-1
• 06974541563666: AU1001S
• 06974541563628: AU1001
• 86974541563143: ST9001-1
• 86974541563105: ST8001-2
• 86974541563082: ST8001-1
• 06974541563673: AU1001-96
• 86974541563556: AU17012
• 86974541563549: AU17012
• 86974541563532: AU17011
• 86974541563525: AU17011
• 86974541563518: AU17011
• 06974541563307: SS001-7
• 06974541563291: SS001-6
• 06974541563284: SS001-5
• 06974541563277: SS001-4
• 06974541563260: SS001-3
• 06974541563253: SS001-2
• 06974541563246: SS001-1
• 86974541564355: ST7001-2
• 86974541564331: ST7001-1
• 06974541564373: ST9001-2
• 06974541564380: BTK-H2202
• 86974541564409: BTK-H2205
• 06974541564397: BTK-H2201
• 06974541564526: ST9001-2