Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name: Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix FDA UDI
Generic Name: Inorganic phosphate (PO43-) IVD, reagent FDA UDI
Device Name: Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix is used for the quantitative determination of inorganic phosphorus in serum or plasma on TC Matrix analyzers. FDA UDI
Model / Reference: I516-780TM FDA UDI
Description: Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix is used for the quantitative determination of inorganic phosphorus in serum or plasma on TC Matrix analyzers. FDA UDI

Identifiers

Catalog Number: I516-780TM FDA UDI
Primary DI / UDI-DI: 10673486001976 FDA UDI
510(k) Number: K881171 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Inorganic phosphate (PO43-) IVD, reagent

Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inorganic phosphate (PO43-) IVD, reagent.

BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Phosphorus UV, 2 x 100 mL — Chronolab Systems, S.L. · IVD General
Liquick Cor-PHOSPHORUS 30 — PZ CORMAY Spółka Akcyjna · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Pointe Scientific, Inc. Phosphorus — POINTE SCIENTIFIC, INC. · Class I
ACCENT-300 PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
Alinity — Abbott · Class I
Fosforo UV — GIESSE DIAGNOSTICS SRL · IVD General

Cleared under the same submission

K881171 also covers:

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 699b89b9-140e-47b2-8df9-2e04ceaa6b11 37 fields · synced Jun 8, 2026