Identity
- Trade Name
- BioSci™ FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Device Name
- 3 mL of Transport Medium in screw-cap tube, One minitip flocking swab with 8cm breaking point and one regular flocking swab with 3cm breaking point FDA UDI
- Model / Reference
- VNO FDA UDI
- Description
- 3 mL of Transport Medium in screw-cap tube, One minitip flocking swab with 8cm breaking point and one regular flocking swab with 3cm breaking point FDA UDI
Identifiers
- Catalog Number
- 6991391 FDA UDI
- Primary DI / UDI-DI
- 16977644780043 FDA UDI
- 510(k) Number
- K220059 FDA UDI
- FDA Product Code
- JSM FDA UDI
- GMDN Term
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen collection kit IVD, clinical
BioSci™ by Shenzhen Dakewe Bio-engineering Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General specimen collection kit IVD, clinical.
- Starswab Anaerobic Transport System — Pretium Canada Packaging ULC · Class I
- Therapak — Therapak LLC · Class I
- Sigma Transwab — Medical Wire & Equipment Company (Bath), Ltd. · Class I
- DHI Specimen Collection System — DIAGNOSTIC HYBRIDS, INC. · Class I
- RENONMED — Zhejiang Renon Medical Instrument Co., Ltd. · Class I
- iClean — Huachenyang (Shenzhen) Technology Co., Ltd
- BioTeke — Bioteke Corporation (Wuxi) Co., Ltd. · Class I
- Therapak — Therapak LLC · Class I
Cleared under the same submission
K220059 also covers:
- Dakewe — SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.
- Dakewe — SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.
- BioSci™ — Shenzhen Dakewe Bio-engineering Co., Ltd
- BioSci™ — Shenzhen Dakewe Bio-engineering Co., Ltd
- BioSci™ — Shenzhen Dakewe Bio-engineering Co., Ltd
- DTPM — Shenzhen Dakewe Bio-engineering Co., Ltd
- DTPM — Shenzhen Dakewe Bio-engineering Co., Ltd
- Dakewe — Shenzhen Dakewe Bio-engineering Co., Ltd
- Dakewe — Shenzhen Dakewe Bio-engineering Co., Ltd
- Dakewe — Shenzhen Dakewe Bio-engineering Co., Ltd
- Dakewe — Shenzhen Dakewe Bio-engineering Co., Ltd
- Dakewe — Shenzhen Dakewe Bio-engineering Co., Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd
Sources (1)
- FDA UDI a86af079-4182-48ab-9058-3a5439defae3 35 fields · synced Jun 1, 2026