Identity
- Trade Name
- IFA CMV IgG Test System FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The ZEUS IFA Cytomegalovirus (CMV) IgG Test System is designed for the qualitative and semi-quantitative detection of anti-CMV IgG antibody in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. FDA UDI
- Model / Reference
- FA9001G FDA UDI
- Description
- The ZEUS IFA Cytomegalovirus (CMV) IgG Test System is designed for the qualitative and semi-quantitative detection of anti-CMV IgG antibody in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. FDA UDI
Identifiers
- Catalog Number
- FA9001G FDA UDI
- Primary DI / UDI-DI
- 00845533001533 FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- 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, fluorescent immunoassay
IFA CMV IgG Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BioPlex 2200 — Bio-Rad Laboratories · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI c52e7a49-af7f-418c-bc1d-419512ea60da 35 fields · synced May 31, 2026