Identity
- Trade Name
- NORMAL SALINE (NS) EUDAMEDNS FDA UDI
- Generic Name
- Isotonic saline reagent IVD FDA UDI
- Device Name
- SALINE DILUENT EUDAMEDThis product should be used in conjunction with RX series reagents to dilute samples prior to assay FDA UDI
- Model / Reference
- SA3854 EUDAMEDFDA UDI
- Description
- This product should be used in conjunction with RX series reagents to dilute samples prior to assay FDA UDI
Identifiers
- Catalog Number
- SA3854 FDA UDI
- Primary DI / UDI-DI
- 05055273206111 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732ASALDIL007DT EUDAMED
- FDA Product Code
- JJF FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Isotonic saline reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2170 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Normal Saline (ns) by Randox Laboratories Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732ASALDIL007DT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED ae96a586-4ab8-4151-9769-a08941267712 61 fields · synced Jul 31, 2026
- FDA UDI 492e7c1d-caa9-4d64-9fd8-3091cd226279 36 fields · synced May 30, 2026