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Cholinesterase Liquid

FDA UDI

Class I (US FDA UDI)

by Sentinel Ch. Srl

Identity

Trade Name
Cholinesterase Liquid FDA UDI
Generic Name
Pseudocholinesterase IVD, reagent FDA UDI
Device Name
The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. FDA UDI
Model / Reference
17019H FDA UDI
Description
The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. FDA UDI

Identifiers

Catalog Number
17019H FDA UDI
Primary DI / UDI-DI
08058056680709 FDA UDI
510(k) Number
K981800 FDA UDI
FDA Product Code
DLI FDA UDI
GMDN Term
Pseudocholinesterase 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

Dimensions & Sizes

Size
Total Volume — 120 Milliliter FDA UDI

Category: Pseudocholinesterase IVD, reagent

Cholinesterase Liquid by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sentinel Ch. Srl

Sources (1)

  • FDA UDI 8d19d14a-9e60-4ca5-b374-05cd838fede6 38 fields · synced May 30, 2026