Identity
- Trade Name
- Genomadix Cube CYP2C19 FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab IVD FDA UDI
- Device Name
- Each unit is a box of 20 swabs. FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- Each unit is a box of 20 swabs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G257ASM001030 FDA UDI
- 510(k) Number
- K220026 FDA UDI
- FDA Product Code
- NTI FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection swab IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3360 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: Oral/upper respiratory tract specimen collection swab IVD
Genomadix Cube CYP2C19 by Genomadix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral/upper respiratory tract specimen collection swab IVD.
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
- Genomadix, Inc.
Sources (1)
- FDA UDI 303ffe6e-b495-4811-b367-3c06ef40b3da 35 fields · synced May 30, 2026