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Teco Diagnostics Cholinesterase Reagent Set

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
Teco Diagnostics Cholinesterase Reagent Set FDA UDI
Generic Name
Cholinesterase dibucaine number (percentage inhibition) IVD, reagent FDA UDI
Device Name
Teco Diagnostics Cholinesterase Reagent Set is used for in vitro diagnostic use in the quantitative kinetic determination of cholinesterase in human serum, plasma, or whole blood. FDA UDI
Model / Reference
C511-60 FDA UDI
Description
Teco Diagnostics Cholinesterase Reagent Set is used for in vitro diagnostic use in the quantitative kinetic determination of cholinesterase in human serum, plasma, or whole blood. FDA UDI

Identifiers

Catalog Number
C511-60 FDA UDI
Primary DI / UDI-DI
10673486001488 FDA UDI
510(k) Number
K914171 FDA UDI
FDA Product Code
DIH FDA UDI
GMDN Term
Cholinesterase dibucaine number (percentage inhibition) IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3240 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: Cholinesterase dibucaine number (percentage inhibition) IVD, reagent

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

Similar devices

Also classified as Cholinesterase dibucaine number (percentage inhibition) IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI 053e590f-aa62-4040-b7e9-5f9e68d61372 37 fields · synced May 29, 2026