Glucagon ELISA

FDA UDI

Class I (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name: Glucagon ELISA FDA UDI
Generic Name: Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma samples. FDA UDI
Model / Reference: 11-GLUHU-E01 FDA UDI
Description: The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma samples. FDA UDI

Identifiers

Catalog Number: 11-GLUHU-E01 FDA UDI
Primary DI / UDI-DI: B24211GLUHUE010 FDA UDI
FDA Product Code: JME FDA UDI
GMDN Term: Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1335 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

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Manufacturing Date

FDA UDI

Category: Glucagon IVD, kit, enzyme immunoassay (EIA)

Glucagon ELISA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucagon IVD, kit, enzyme immunoassay (EIA).

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DBC Glucagon ELISA — Diagnostics Biochem Canada Inc · Class I
Ansh Labs Glucagon ELISA — Ansh Labs, LLC
Ansh Labs Glucagon ELISA — Ansh Labs, LLC
MP Biomedicals LLC — MP BIOMEDICALS, LLC · Class I
Glucagon RIA — American Laboratory Products Company · Class I

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 I	Pending data

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Manufacturer

Manufacturer: American Laboratory Products Company

Sources (1)

FDA UDI ab4397c8-d11f-4352-8862-a898276d3383 35 fields · synced May 30, 2026