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Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- Swab Male Urethral Specimen Collection FDA UDI
- Model / Reference
- 441358 FDA UDI
- Description
- Swab Male Urethral Specimen Collection FDA UDI
Identifiers
- Catalog Number
- 441358 FDA UDI
- Primary DI / UDI-DI
- 00382904413583 FDA UDI
- 510(k) Number
- K081825 FDA UDI
- FDA Product Code
- LSL FDA UDI
- GMDN Term
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 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
Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical.
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- Visby Medical Power Adapter, Right Angle — Visby Medical, Inc. · Class II
Cleared under the same submission
K081825 also covers:
- BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens — BECTON DICKINSON AND COMPANY
- BD Vaginal Specimen Transport for the BD ProbeTec™ Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY
- BD Viper™ Extraction Reagent and Lysis Trough — BECTON DICKINSON AND COMPANY
- Control Set for the BD ProbeTec™ (CT/GC) — BECTON DICKINSON AND COMPANY
- Urine Preservative Transport for the BD ProbeTec™ Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY
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 a54a0eb1-bed7-4982-a97f-8642c4ba1be8 37 fields · synced May 30, 2026