Identity
- Trade Name
- DTPM FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection kit FDA UDI
- Device Name
- 3 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs and oropharyngeal swabs. FDA UDI
- Model / Reference
- ITMNO FDA UDI
- Description
- 3 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs and oropharyngeal swabs. FDA UDI
Identifiers
- Catalog Number
- PV993240 FDA UDI
- Primary DI / UDI-DI
- 06973471968763 FDA UDI
- 510(k) Number
- K220059 FDA UDI
- FDA Product Code
- QBD FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection kit 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
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: Oral/upper respiratory tract specimen collection kit
Dtpm by Shenzhen Dakewe Bio-engineering Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- BioSci™ — 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 411b9baf-11f1-413b-91d1-cbd71f33533d 35 fields · synced May 30, 2026