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IgG

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
IgG FDA UDI
Generic Name
Total immunoglobulin G (IgG total) IVD, antibody FDA UDI
Device Name
The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma FDA UDI
Model / Reference
IG7158 FDA UDI
Description
The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma FDA UDI

Identifiers

Catalog Number
IG7158 FDA UDI
Primary DI / UDI-DI
05055273203974 FDA UDI
510(k) Number
K955798 FDA UDI
FDA Product Code
DEW FDA UDI
GMDN Term
Total immunoglobulin G (IgG total) IVD, antibody 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: Total immunoglobulin G (IgG total) IVD, antibody

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

Similar devices

Also classified as Total immunoglobulin G (IgG total) IVD, antibody.

Cleared under the same submission

K955798 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 18e9fe41-07fe-4158-bffc-ad062f07550e 37 fields · synced May 31, 2026