Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set

FDA UDI

Class II (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name: Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set FDA UDI
Generic Name: Total creatine kinase (CK) IVD, reagent FDA UDI
Device Name: Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set is used for the quantitative determination of creatine kinase in human serum. FDA UDI
Model / Reference: C512-60 FDA UDI
Description: Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set is used for the quantitative determination of creatine kinase in human serum. FDA UDI

Identifiers

Catalog Number: C512-60 FDA UDI
Primary DI / UDI-DI: 10673486001495 FDA UDI
510(k) Number: K864744 FDA UDI
FDA Product Code: CGS FDA UDI
GMDN Term: Total creatine kinase (CK) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1215 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: Total creatine kinase (CK) IVD, reagent

Teco Diagnostics Creatine Kinase (CK-NAC) 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

K864744 also covers:

Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set — 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 30ba1fd7-1e72-4bd6-90be-3367bdd03a21 37 fields · synced May 30, 2026