Identity
- Trade Name
- binx io FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- Female collection kit FDA UDI
- Model / Reference
- V1 (CT/NG) FDA UDI
- Description
- Female collection kit FDA UDI
Identifiers
- Catalog Number
- 5.012.001 FDA UDI
- Primary DI / UDI-DI
- 05060441760043 FDA UDI
- 510(k) Number
- K200533 FDA UDI
- FDA Product Code
- LIO 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
- 866.2900 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
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
binx io by Binx Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical.
- Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack — Visby Medical, Inc. · Class II
- Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY · Class II
- cobas® PCR Urine Sample Kit — Roche Molecular Systems, Inc. · Class II
- Aptima® — Hologic, Inc. · Class I
- BD Vaginal Specimen Transport for the BD ProbeTec™ Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY · Class II
- Visby Medical Power Adapter — Visby Medical, Inc. · Class II
- BD Molecular Swab Collection Kit — BECTON DICKINSON AND COMPANY · Class II
- Visby Medical Women's Sexual Health Test — Visby Medical, Inc. · Class II
Cleared under the same submission
K200533 also covers:
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
- Binx Health, Inc.
Sources (1)
- FDA UDI d0c8f2f1-ab74-49d1-b040-1d768ac7f4d3 35 fields · synced May 30, 2026