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alpha 1-Acid Glycoprotein

FDA UDI

Class I (US FDA UDI)

by Sentinel Ch. Srl

Identity

Trade Name
alpha 1-Acid Glycoprotein FDA UDI
Generic Name
Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent FDA UDI
Device Name
The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. For In Vitro Diagnostic Use only. FDA UDI
Model / Reference
A26838 FDA UDI
Description
The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. For In Vitro Diagnostic Use only. FDA UDI

Identifiers

Catalog Number
A26838 FDA UDI
Primary DI / UDI-DI
08058056680648 FDA UDI
FDA Product Code
LKL FDA UDI
GMDN Term
Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.5420 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

Dimensions & Sizes

Size
Total Volume — 88 Milliliter FDA UDI

Category: Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent

alpha 1-Acid Glycoprotein by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alpha-1-acid glycoprotein (orosomucoid) 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 cccbfe42-8328-4d2f-bdcc-9d63a37eeec7 37 fields · synced May 31, 2026