Identity
- Trade Name
- Teco Diagnostics Sodium Reagent Set FDA UDI
- Generic Name
- Sodium (Na+) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Sodium Reagent Set is used for the colorimetric determination of sodium in human serum and plasma. FDA UDI
- Model / Reference
- S600-50 FDA UDI
- Description
- Teco Diagnostics Sodium Reagent Set is used for the colorimetric determination of sodium in human serum and plasma. FDA UDI
Identifiers
- Catalog Number
- S600-50 FDA UDI
- Primary DI / UDI-DI
- 10673486002188 FDA UDI
- 510(k) Number
- K902572 FDA UDI
- FDA Product Code
- CEI FDA UDI
- GMDN Term
- Sodium (Na+) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 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
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
Category: Sodium (Na+) IVD, reagent
Teco Diagnostics Sodium Reagent Set by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sodium (Na+) IVD, reagent.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 96d7b6a3-a0af-4ee7-8849-a95fbfd7bb5a 37 fields · synced May 30, 2026