Identity
- Trade Name
- Dakewe 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 oropharyngeal swabs. 50 tests per package. FDA UDI
- Model / Reference
- ITMO FDA UDI
- Description
- 3 mL of Inactivated Transport Medium in screw-cap tube, with oropharyngeal swabs. 50 tests per package. FDA UDI
Identifiers
- Catalog Number
- 3983321 FDA UDI
- Primary DI / UDI-DI
- 06973471960583 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
Dakewe by Shenzhen Dakewe Bio-engineering Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral/upper respiratory tract specimen collection kit.
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- Molecular Transport Media (MTM) 3ml — A. L. B. LUZ · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Salivette® Cortisol, code blue — Sarstedt Aktiengesellschaft & Co.KG · Class I
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- OraSure HIV-1 Oral Specimen Collection Device — OraSure Technologies, Inc. · Class III
- Immunalysis — Immunalysis Corporation · 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
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd
Sources (1)
- FDA UDI 1e807baf-cd66-46e0-b036-9d429b973083 35 fields · synced Jun 6, 2026