Teco Diagnostics Chloride Reagent Set

FDA UDI

Class II (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name: Teco Diagnostics Chloride Reagent Set FDA UDI
Generic Name: Chloride (Cl-) IVD, reagent FDA UDI
Device Name: Teco Diagnostics Chloride Reagent Set is used for the quantitative colorimetric determination of chloride in human serum. FDA UDI
Model / Reference: C501-480 FDA UDI
Description: Teco Diagnostics Chloride Reagent Set is used for the quantitative colorimetric determination of chloride in human serum. FDA UDI

Identifiers

Catalog Number: C501-480 FDA UDI
Primary DI / UDI-DI: 10673486001334 FDA UDI
510(k) Number: K883386 FDA UDI
FDA Product Code: CHJ FDA UDI
GMDN Term: Chloride (Cl-) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1170 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: Chloride (Cl-) IVD, reagent

Teco Diagnostics Chloride Reagent Set by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K883386 also covers:

Teco Diagnostics Chloride Reagent Set TC Matrix — TECO DIAGNOSTICS

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

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Manufacturer

Manufacturer: Teco Diagnostics

Sources (1)

FDA UDI a7650bdc-eec3-4eaf-80ca-822cb3f8c27d 37 fields · synced Jun 6, 2026