Identity
- Trade Name
- BD Molecular Urine Transport Kit FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- Molecular Urine Transport Kit 96EA FDA UDI
- Model / Reference
- 443924 FDA UDI
- Description
- Molecular Urine Transport Kit 96EA FDA UDI
Identifiers
- Catalog Number
- 443924 FDA UDI
- Primary DI / UDI-DI
- 00382904439248 FDA UDI
- 510(k) Number
- K182692 FDA UDI
- FDA Product Code
- LSL FDA UDIMKZ FDA UDIOUY FDA UDI
- GMDN Term
- Urine specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 FDA UDI866.3120 FDA UDI866.3860 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: Urine specimen collection kit IVD
BD Molecular Urine Transport Kit by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Becton Dickinson And Company
Sources (1)
- FDA UDI e9954d3d-a34b-4414-966a-88e319caadca 37 fields · synced May 30, 2026