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Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit FDA UDI
- Generic Name
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection. FDA UDI
- Model / Reference
- 720-520 FDA UDI
- Description
- ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection. FDA UDI
Identifiers
- Catalog Number
- 720-520 FDA UDI
- Primary DI / UDI-DI
- B3507205200 FDA UDI
- 510(k) Number
- K974552 FDA UDI
- FDA Product Code
- LJB FDA UDI
- GMDN Term
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3520 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
No
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: Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit by Gold Standard Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- ASI Measles IgG EIA Test — Arlington Scientific, Inc. · Class I
- SeraQuest — QUEST INTERNATIONAL, INC. · Class I
- ReQuest — QUEST INTERNATIONAL, INC. · Class I
- VIDAS® Measles IgG — BIOMERIEUX , INC. · Class I
- QMedix™ — Diagnostic Automation, Inc. · Class I
- NovaLisa Measles Virus IgG — Gold Standard Diagnostics Frankfurt GmbH · Class I
- ELISA Measles IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
Cleared under the same submission
K974552 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 023e576f-4eaa-4faf-89d8-6a832e3849e3 36 fields · synced Jun 8, 2026