Identity
- Trade Name
- PROBETEC EUDAMEDDilution Tubes (LBC) for the BD ProbeTec™ Qx Amplified DNA Assays FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- BD Liquid-Based Cytology Specimen (LBC) Dilution Tubes for the BD ProbeTec™ Qx Amplified DNA Assays EUDAMEDTube LBC Diluent Qx FDA UDI
- Model / Reference
- 441444 EUDAMEDFDA UDI
- Description
- Tube LBC Diluent Qx FDA UDI
Identifiers
- Catalog Number
- 441444 FDA UDI
- Primary DI / UDI-DI
- 30382904414444 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290KJMCIFTK7N EUDAMED
- Unit of Use DI
- 00382904414443 EUDAMED
- FDA Product Code
- LSL FDA UDIMKZ FDA UDI
- EMDN Code
- W0104010204 SAMPLE TRANSPORT FOR NA TESTING EUDAMED
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3390 FDA UDI866.3120 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Probetec by Becton, Dickinson and Company — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290KJMCIFTK7N | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (2)
- EUDAMED e7ed5ddf-0575-4faa-b470-5b547dd1732e 61 fields · synced Oct 6, 2026
- FDA UDI 3779d955-20fc-44a9-b1d5-6d748d086a58 36 fields · synced May 30, 2026