Identity
- Trade Name
- BioSci™ FDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
- Device Name
- 2 mL of Inactivated Transport Medium. 100 tests per package. FDA UDI
- Model / Reference
- ITMM FDA UDI
- Description
- 2 mL of Inactivated Transport Medium. 100 tests per package. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973471968510 FDA UDI
- 510(k) Number
- K220059 FDA UDI
- FDA Product Code
- QBD FDA UDI
- GMDN Term
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2950 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
No
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: Oral/respiratory tract specimen container IVD, additive/medium
BioSci™ by Shenzhen Dakewe Bio-engineering Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oral/respiratory tract specimen container IVD, additive/medium.
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- BioMAX — Spectrum Solutions L.L.C. · Class II
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- Dakewe — SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd
Sources (1)
- FDA UDI 7573c08a-b67f-4872-bb17-186b8ab6bf36 34 fields · synced Jun 8, 2026