Identity
- Trade Name
- BD Molecular LBC Sample Buffer Tubes FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- Molecular LBC Sample Buffer Tubes 48EA FDA UDI
- Model / Reference
- 443923 FDA UDI
- Description
- Molecular LBC Sample Buffer Tubes 48EA FDA UDI
Identifiers
- Catalog Number
- 443923 FDA UDI
- Primary DI / UDI-DI
- 30382904439232 FDA UDI
- 510(k) Number
- K182692 FDA UDI
- FDA Product Code
- MKZ FDA UDIOUY FDA UDILSL FDA UDI
- GMDN Term
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3120 FDA UDI866.3860 FDA UDI866.3390 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: Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
BD Molecular LBC Sample Buffer Tubes by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical.
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- binx io — Binx Health, Inc. · Class I
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI d3c7444f-0eaf-4d72-85fb-dee2c74b0e47 37 fields · synced May 30, 2026