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ReQuest

FDA UDI

Class I (US FDA UDI)

by Quest International, Inc.

Identity

Trade Name
ReQuest FDA UDI
Generic Name
Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
Mumps M FDA UDI
Description
Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Identifiers

Catalog Number
Q01-200M FDA UDI
Primary DI / UDI-DI
00850487007081 FDA UDI
FDA Product Code
LJY FDA UDI
GMDN Term
Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest by Quest International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quest International, Inc.

Sources (1)

  • FDA UDI 27a2f7d7-c846-480c-bf43-502f6c1cae0c 35 fields · synced Jun 8, 2026