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Lipase NG OC Reagent Kit

FDA UDI

Class I (US FDA UDI)

by Sentinel Ch. Srl

Identity

Trade Name
Lipase NG OC Reagent Kit FDA UDI
Generic Name
Lipase IVD, reagent FDA UDI
Device Name
The Lipase NG OC assay is an in vitro diagnostic test used for the determination of the Lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. For In Vitro Diagnostic use. FDA UDI
Model / Reference
04Y85-20 FDA UDI
Description
The Lipase NG OC assay is an in vitro diagnostic test used for the determination of the Lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. For In Vitro Diagnostic use. FDA UDI

Identifiers

Catalog Number
04Y85-20 FDA UDI
Primary DI / UDI-DI
08058056682321 FDA UDI
FDA Product Code
CHI FDA UDI
GMDN Term
Lipase IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1465 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Lipase IVD, reagent

Lipase NG OC Reagent Kit by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lipase IVD, reagent.

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 510d5990-69a1-4d0c-a32b-c7eefed54bbc 36 fields · synced Jun 1, 2026