ORAcollect Dx
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- ORAcollect Dx EUDAMEDFDA UDI
- Generic Name
- Specimen stabilization reagent IVD FDA UDI
- Device Name
- ORAcollect (Swab based DNA & Dx Collection Device) EUDAMEDDNA Specimen Collection, Saliva FDA UDI
- Model / Reference
- OCD-100 EUDAMEDFDA UDI
- Description
- DNA Specimen Collection, Saliva FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627595000309 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627595B0200EX EUDAMED
- FDA Product Code
- OYJ FDA UDI
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
- GMDN Term
- Specimen stabilization reagent IVD FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General-purpose absorbent tip applicator/swab, single-use
ORAcollect Dx by DNA Genotek Inc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
- Disposable Sterile Swabs — Hangzhou Yiguoren Biotechnology Co.,Ltd. · Class I
- NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc. · Class I
- Disposable Collection Tubes of Virus Samples — Jiangsu Mole Bioscience Co., LTD. · Class A
- ESCOB. PS FLOCK NASOF. 80MM EN TUBO — Deltalab, S.L. · Class IIa
- Disposable sampling swab — Jiangsu HanHeng Medical Technology Co., Ltd. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152464 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0627595B0200EX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DNA Genotek Inc.
- EUDAMED SRN
- CA-MF-000003486
- FDA Applicant
- DNA Genotek, Inc.
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED e0f9716e-135e-4d0f-81ce-a11b88d8b925 85 fields · synced Jun 19, 2026
- FDA UDI 4f3538d2-4ec0-427c-bbc9-39172bff38e2 35 fields · synced May 30, 2026
- FDA 510(k) K152464 1 fields · synced May 18, 2026