Identity
- Trade Name
- Rhinostics, Inc. FDA UDI
- Generic Name
- General specimen collection kit IVD, home-use FDA UDI
- Device Name
- Rhinostics Standard Swab FDA UDI
- Model / Reference
- PG-100001 FDA UDI
- Description
- Rhinostics Standard Swab FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042963005 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- General specimen collection kit IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral/upper respiratory tract specimen collection swabGeneral specimen collection kit IVD, home-use
Rhinostics, Inc. by Rhinostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General specimen collection kit IVD, home-use.
- LetsGetChecked Blood and Urine Sample Collection Kit (ST05) — PRIVAPATH DIAGNOSTICS LIMITED
- Rhinostics, Inc. — Rhinostics Inc · Class I
- Rhinostics, Inc. — Rhinostics Inc · Class I
- Rhinostics, Inc. — Rhinostics Inc · Class I
- Rhinostics, Inc. — Rhinostics Inc · Class I
- Rhinostics, Inc. — Rhinostics Inc · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rhinostics Inc
Sources (1)
- FDA UDI e29b995f-239e-43da-98b6-1e403449cbda 33 fields · synced Jun 8, 2026