Identity
- Trade Name
- MERIFLUOR EBV-EA IgG IFA FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The MERIFLUOR EBV-EA IgG IFA Test is a sensitive and rapid immunofluorescence method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human serum. When performed according to instructions, the MERIFLUOR EBV-EA IgG IFA Test detects IgG antibodies to the diffuse (D) and restricted (R) components of the EBV-EA complex. It is of value in providing supportive information for the diagnosis of EBV associated disease. FDA UDI
- Model / Reference
- EA101 FDA UDI
- Description
- The MERIFLUOR EBV-EA IgG IFA Test is a sensitive and rapid immunofluorescence method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human serum. When performed according to instructions, the MERIFLUOR EBV-EA IgG IFA Test detects IgG antibodies to the diffuse (D) and restricted (R) components of the EBV-EA complex. It is of value in providing supportive information for the diagnosis of EBV associated disease. FDA UDI
Identifiers
- Catalog Number
- EA101 FDA UDI
- Primary DI / UDI-DI
- 00840733103247 FDA UDI
- 510(k) Number
- K872617 FDA UDI
- FDA Product Code
- LSE FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3235 FDA UDI
- Commercial Distribution
- Not 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
MERIFLUOR EBV-EA IgG IFA by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 7bd01ccb-541a-412b-b9f5-9127a72f2efd 38 fields · synced May 30, 2026