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Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit

FDA UDI

Class II (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit FDA UDI
Generic Name
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age. FDA UDI
Model / Reference
720-360 FDA UDI
Description
ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age. FDA UDI

Identifiers

Catalog Number
720-360 FDA UDI
Primary DI / UDI-DI
B3507203600 FDA UDI
510(k) Number
K981729 FDA UDI
FDA Product Code
LFX FDA UDI
GMDN Term
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) 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

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

Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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

Cleared under the same submission

K981729 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gold Standard Diagnostics, LLC

Sources (1)

  • FDA UDI 8ca2657f-64ca-404a-9b77-798d371e8f8f 36 fields · synced Jun 8, 2026