Identity
- Trade Name
- SelectaLyte FDA UDI
- Generic Name
- Ion-selective analyser IVD, semi-automated FDA UDI
- Model / Reference
- 3910 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850229007287 FDA UDI
- 510(k) Number
- K171476 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Ion-selective analyser IVD, semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ion-selective analyser IVD, semi-automated
SelectaLyte by Awareness Technology, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ion-selective analyser IVD, semi-automated.
- Sensor Module, Li+ — Siemens Healthcare Diagnostics · Class II
- RAPIDChem® 744 — Siemens Healthcare Diagnostics · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Awareness Technology, Incorporated
Sources (1)
- FDA UDI fcd53e9c-5887-4814-92e6-67709de49e6d 33 fields · synced Jun 8, 2026