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DNA/RNA Shield SafeCollect Saliva Collection Kit
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref R1211-EModel R1160-E510(k) K231013
Identity
- Trade Name
- DNA/RNA Shield SafeCollect Saliva Collection Kit EUDAMED
- Device Name
- DNA/RNA Shield SafeCollect Swab Collection Kit (1mL) EUDAMED
- Model / Reference
- R1160-E EUDAMEDR1211-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027600116 EUDAMED
- Basic UDI-DI
- 0850027600R1160FL EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
DNA/RNA Shield SafeCollect Saliva Collection Kit by Zymo Research Corp. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231013 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 0850027600R1160FL | Class A | Active |
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Manufacturer
- Manufacturer
- Zymo Research Corp.
- EUDAMED SRN
- US-MF-000019308
- FDA Applicant
- Zymo Research
- Authorised Representative
- DAVID Catherine Elisabeth Marie FR-AR-000006724
Sources (2)
- EUDAMED 3ff14be2-21d7-4066-b031-ef7771edd647 85 fields · synced Jun 19, 2026
- FDA 510(k) K231013 1 fields · synced May 18, 2026