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Rubella IgG IFA 96 Test

FDA UDI

Class II (US FDA UDI)

by Hemagen Diagnostics, Inc.

Identity

Trade Name
Rubella IgG IFA 96 Test FDA UDI
Generic Name
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
For the detection and titration of rubella virus IgG antibodies in human sera FDA UDI
Model / Reference
902700 FDA UDI
Description
For the detection and titration of rubella virus IgG antibodies in human sera FDA UDI

Identifiers

Primary DI / UDI-DI
G5229027001 FDA UDI
510(k) Number
K792635 FDA UDI
FDA Product Code
LSD FDA UDI
GMDN Term
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3510 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

No

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: Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Rubella IgG IFA 96 Test by Hemagen Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K792635 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hemagen Diagnostics, Inc.

Sources (1)

  • FDA UDI 372e4705-bb58-42ef-ac7a-80baa744cbef 36 fields · synced May 30, 2026