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IgA

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
IgA FDA UDI
Generic Name
Immunoglobulin A antibody (anti-IgA) IVD, reagent FDA UDI
Device Name
The product is intended for the quantitative in vitro determination of IgA in serum or plasma. FDA UDI
Model / Reference
IA7157 FDA UDI
Description
The product is intended for the quantitative in vitro determination of IgA in serum or plasma. FDA UDI

Identifiers

Catalog Number
IA7157 FDA UDI
Primary DI / UDI-DI
05055273203905 FDA UDI
510(k) Number
K955794 FDA UDI
FDA Product Code
CZP FDA UDI
GMDN Term
Immunoglobulin A antibody (anti-IgA) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Immunoglobulin A antibody (anti-IgA) IVD, reagent

IgA by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Immunoglobulin A antibody (anti-IgA) IVD, reagent.

Cleared under the same submission

K955794 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 0545d490-ac34-41e8-ae1a-88436fb5254d 37 fields · synced Jun 1, 2026