BioSci™ 6991121

GUDID 16973471960948

1 mL of Transport Medium in screw-cap tube, with regular flocking swab. 50 tests per package

Shenzhen Dakewe Bio-engineering Co., Ltd

General specimen collection kit IVD, clinical

• Primary Device ID: 16973471960948
• NIH Device Record Key: 2be8df21-bece-4579-a978-d1aa3ee5bba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSci™
• Version Model Number: VO
• Catalog Number: 6991121
• Company DUNS: 543029175
• Company Name: Shenzhen Dakewe Bio-engineering Co., Ltd
• Device Count: 1
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973471960941 [Primary]
GS1	16973471960948 [Package]; Contains: 06973471960941; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230035

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2023-07-12
• Device Publish Date: 2023-07-04

On-Brand Devices [BioSci™]

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• 06973471961085: 2 mL of Transport Medium in screw-cap tube. 100 tests per package
• 06973471961078: 1.5 mL of Transport Medium in screw-cap tube. 100 tests per package
• 06973471961061: 1 mL of Transport Medium in screw-cap tube. 100 tests per package
• 16973471961037: 3 mL of Transport Medium in screw-cap tube, with minitip flocking swab and regular flocking swa
• 16973471961020: 1 mL of Transport Medium in screw-cap tube, with minitip flocking swab and regular flocking swa
• 06973471960958: 3 mL of Transport Medium in screw-cap tube, with regular flocking swab. 50 tests per package
• 16973471960948: 1 mL of Transport Medium in screw-cap tube, with regular flocking swab. 50 tests per package
• 16973471960931: 3 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 tests per package
• 06973471960927: 1 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 tests per package
• 06973471960705: 3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with nasopharyngeal swab.
• 06973471968527: 3 mL of Inactivated Transport Medium. 100 tests per package.
• 06973471968510: 2 mL of Inactivated Transport Medium. 100 tests per package.
• 06973471968503: 1 mL of Inactivated Transport Medium . 100 tests per package.
• 26977644780002: 3 mL of Transport Medium in screw-cap tube, with minitip flocking swab.
• 06973471969999: 1 mL of Transport Medium in screw-cap tube, with minitip flocking swab.
• 26973471969948: 3 mL of Transport Medium in screw-cap tube
• 26977644780019: 1 mL of Transport Medium in screw-cap tube, with regular flocking swab.
• 26977644780040: 3 mL of Transport Medium in screw-cap tube, One minitip flocking swab with 8cm breaking point an
• 26977644780033: 1 mL of Transport Medium in screw-cap tube, One minitip flocking swab with 8cm breaking point an
• 26977644780026: 3 mL of Transport Medium in screw-cap tube,One regular flocking swab with 3cm breaking point