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Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals. FDA UDI
- Model / Reference
- 720-320 FDA UDI
- Description
- ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals. FDA UDI
Identifiers
- Catalog Number
- 720-320 FDA UDI
- Primary DI / UDI-DI
- B3507203200 FDA UDI
- 510(k) Number
- K981163 FDA UDI
- FDA Product Code
- LFZ FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 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: Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ASI CMV IgG EIA Test — Arlington Scientific, Inc. · Class II
- Pointe Scientific, Inc. CMV IgG — POINTE SCIENTIFIC, INC. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- VIDAS® CMV IgG — BIOMERIEUX , INC. · Class II
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- CMV IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- CMV IgG ELISA — DRG International, Inc. · Class II
Cleared under the same submission
K981163 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 II | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI a5bb5d21-fe85-4a9c-8420-e78a53158c5c 36 fields · synced Jun 8, 2026