Identity
- Trade Name
- ORAcollect Dx FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab FDA UDI
- Device Name
- DNA Specimen Collection, Saliva FDA UDI
- Model / Reference
- OCD-100.014 FDA UDI
- Description
- DNA Specimen Collection, Saliva FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000712 FDA UDI
- FDA Product Code
- OYJ FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection swab FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
Yes
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
ORAcollect Dx by DNA Genotek Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Cultura™ — Merit Medical Systems, Inc. · Class I
- Sterile Specimen Collection Swab — APPLIED MEDICAL RESOURCES CORP. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- DNA Genotek Inc
Sources (1)
- FDA UDI 7d5b9e85-da78-46a7-9e2b-2f88a1c068b7 35 fields · synced Jun 8, 2026