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Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method) FDA UDI
- Generic Name
- Inorganic phosphate (PO43-) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method) is used for the quantitative determination of inorganic phosphorus in human serum. FDA UDI
- Model / Reference
- I515-480 FDA UDI
- Description
- Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method) is used for the quantitative determination of inorganic phosphorus in human serum. FDA UDI
Identifiers
- Catalog Number
- I515-480 FDA UDI
- Primary DI / UDI-DI
- 10673486001945 FDA UDI
- 510(k) Number
- K915708 FDA UDI
- FDA Product Code
- CEO FDA UDI
- GMDN Term
- Inorganic phosphate (PO43-) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1580 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: Inorganic phosphate (PO43-) IVD, reagent
Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method) by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI cd83428a-f51f-4729-aea5-bd4cd346497c 37 fields · synced May 30, 2026