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Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack. FDA UDI
- Model / Reference
- PS-000715 FDA UDI
- Description
- Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack. FDA UDI
Identifiers
- Catalog Number
- PS-000715 FDA UDI
- Primary DI / UDI-DI
- 00810031720057 FDA UDI
- 510(k) Number
- K200748 FDA UDI
- FDA Product Code
- LSL FDA UDIMKZ FDA UDIOUY 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 UDI866.3120 FDA UDI866.3860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Category: Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack by Visby Medical, Inc. — 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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- BD Vaginal Specimen Transport for the BD ProbeTec™ Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY · Class II
- binx io — Binx Health, Inc. · Class I
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- Aptima® — Hologic, Inc. · Class II
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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
- Visby Medical, Inc.
Sources (1)
- FDA UDI c455a516-eb6c-4a13-9ae1-a6445cdd3c03 35 fields · synced May 30, 2026